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First-time-in-human (FTIH) Study of GSK3145095 Alone and in Combination With Other Anticancer Agents in Adults With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03681951
Recruitment Status : Not yet recruiting
First Posted : September 24, 2018
Last Update Posted : September 24, 2018
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
In an unbiased CRISPR screen, RIPK1 was identified as a top gene contributing to immunotherapy resistance. In addition, RIPK1 has been reported to drive pancreatic oncogenesis. In murine models, inhibition of RIPK1 kinase activity in the pancreatic tumor microenvironment leads to the replacement of tumor-permissive myeloid infiltrates with innate cells that promote an effective antitumor response by adaptive cells. The investigators hypothesize that inhibition of RIPK1 in human pancreatic cancer subjects will modulate the immune infiltrate to sensitize tumors to checkpoint blockade.

Condition or disease Intervention/treatment Phase
Neoplasms, Pancreatic Drug: GSK3145095 Drug: Pembrolizumab Phase 2

Detailed Description:
Study 205013 is a Phase 1 FTIH study of GSK3145095 alone and in combination with other anticancer agents including pembrolizumab in subjects with pancreatic ductal adenocarcinoma (PDAC) and other selected tumors. The study includes up to 4 parts: Part 1 dose escalation will be conducted in approximately 30 adult subjects with advanced or metastatic PDAC using escalating doses of GSK3145095 as monotherapy only. Part 2 will combine escalating doses of GSK3145095 with 200 milligram (mg) pembrolizumab. Dose escalation of GSK3145095 will begin at least one level below the highest dose shown to have an acceptable toxicity profile in at least 3 subjects in Part 1. Part 2 may be conducted in a broader population of selected solid tumors using a combination of escalating doses of GSK3145095 and 200 mg pembrolizumab. Part 3 will enroll subjects treated with one or more dose levels of GSK3145095 in combination with 200 mg pembrolizumab. Part 4 will investigate the combination of additional anticancer agents with one or more doses of GSK3145095 identified as safe in Part 1. Up to approximately 220 subjects will be treated in the study. Parts 1 and 2 will each treat up to approximately 30 subjects. Parts 3 and 4 will treat up to approximately 160 subjects (up to 80 subjects in each Part). The total duration of the study is expected to last up to 2 years.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Part 1 dose escalation will administer escalating doses of GSK3145095 as monotherapy only. Part 2 will combine escalating doses of GSK3145095 with 200 mg pembrolizumab. Dose escalation of GSK3145095 will begin at least one level below the highest dose shown to have an acceptable toxicity profile in at least 3 subjects in Part 1. Part 3 will enroll subjects treated with one or more dose levels of GSK3145095 in combination with 200 mg pembrolizumab. Part 4 will investigate the combination of additional anticancer agents with one or more doses of GSK3145095 identified as safe in Part 1.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-Label Study to Investigate the Safety, Clinical Activity, Pharmacokinetics, and Pharmacodynamics of GSK3145095 Administered Alone and in Combination With Anticancer Agents Including Pembrolizumab in Adult Participants With Selected Advanced Solid Tumors
Estimated Study Start Date : November 6, 2018
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1: Dose Escalation - GSK3145095 monotherapy
In Part 1, advanced or metastatic PDAC will be enrolled. Part 1 will be using escalating doses of GSK3145095 (100 mg, 200 mg, 400 mg, 800 mg, and 1600 mg) orally as monotherapy only twice daily (BID) for up to 2 years. Subjects will receive a single dose of GSK3145095 on Day 1 with the BID schedule starting on Day 2.
Drug: GSK3145095
GSK3145095 will be available as capsule (size 1 containing 5 to 25 mg GSK3145095 and size 0 containing 25 to 75 mg GSK3145095) or tablet (25, 50, 200 mg white to slightly covered round/oval shaped coated) for oral administration in the fasted stated with approximately 200 milliliters (mL) of water.

Experimental: Part 2: Dose Escalation - GSK3145095 + pembrolizumab
In Part 2, subjects with selected solid tumors, including but not limited to, PDAC, NSCLC, TNBC and/or melanoma will be enrolled. Part 2 will be using GSK3145095 combination escalation to start at least one dose level below the highest dose of GSK3145095 shown to be safe in Part 1, orally BID for up to 2 years along with pembrolizumab 200 mg intravenous (IV) every 3 weeks (Q3W) for up to 2 years.
Drug: GSK3145095
GSK3145095 will be available as capsule (size 1 containing 5 to 25 mg GSK3145095 and size 0 containing 25 to 75 mg GSK3145095) or tablet (25, 50, 200 mg white to slightly covered round/oval shaped coated) for oral administration in the fasted stated with approximately 200 milliliters (mL) of water.

Drug: Pembrolizumab
Pembrolizumab will be available as solution for infusion (100 milligrams/ 4 milliliter) at a dose of 200 mg via IV infusion for 30 minutes (given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted i.e., infusion time is 25 to 40 minutes).

Experimental: Part 3: Dose Expansion - GSK3145095 + pembrolizumab
In Part 3, subjects with selected solid tumors will be enrolled. Part 3 will be using GSK3145095 at one or two dose levels shown to be tolerable in Part 2 orally BID for up to 2 years along with pembrolizumab 200 mg IV Q3W for up to 2 years.
Drug: GSK3145095
GSK3145095 will be available as capsule (size 1 containing 5 to 25 mg GSK3145095 and size 0 containing 25 to 75 mg GSK3145095) or tablet (25, 50, 200 mg white to slightly covered round/oval shaped coated) for oral administration in the fasted stated with approximately 200 milliliters (mL) of water.

Drug: Pembrolizumab
Pembrolizumab will be available as solution for infusion (100 milligrams/ 4 milliliter) at a dose of 200 mg via IV infusion for 30 minutes (given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted i.e., infusion time is 25 to 40 minutes).

Experimental: Part 4: Dose Expansion - GSK3145095 + anticancer agent
In Part 4, subjects with selected solid tumors will be enrolled. Part 4 will be using GSK3145095 at one or two dose levels shown to be tolerable in Part 2 orally BID for up to 2 years along with combination of additional anticancer agents.
Drug: GSK3145095
GSK3145095 will be available as capsule (size 1 containing 5 to 25 mg GSK3145095 and size 0 containing 25 to 75 mg GSK3145095) or tablet (25, 50, 200 mg white to slightly covered round/oval shaped coated) for oral administration in the fasted stated with approximately 200 milliliters (mL) of water.




Primary Outcome Measures :
  1. Number of subjects with adverse events (AEs) and serious adverse events (SAEs)-Part 1 [ Time Frame: Up to 2 years ]
    An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

  2. Number of subjects with AEs and SAEs-Part 2 [ Time Frame: Up to 2 years ]
    An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

  3. Number of subjects with AEs and SAEs defined by severity-Part 1 [ Time Frame: Up to 2 years ]
    AE and SAE classified as per severity mild, moderate and severe will be presented.

  4. Number of subjects with AEs and SAEs defined by severity-Part 2 [ Time Frame: Up to 2 years ]
    AE and SAE classified as per severity mild, moderate and severe will be presented.

  5. Number of subjects with dose-limiting toxicities (DLTs)-Part 1 [ Time Frame: Up to 2 years ]
    An AE is considered to be a DLT if it is considered by the investigator to be clinically relevant and is attributed to the study treatment and meets at least 1 of the pre-specified criteria.

  6. Number of subjects with DLTs-Part 2 [ Time Frame: Up to 2 years ]
    An AE is considered to be a DLT if it is considered by the investigator to be clinically relevant and is attributed to the study treatment and meets at least 1 of the pre-specified criteria.

  7. Percentage of subjects achieving complete response or partial response based on response evaluation criteria in solid tumors (RECIST) 1.1 criteria Part 3 [ Time Frame: Up to 2 years ]
    The objective response rate (complete response and partial response) was determined by the investigator assessment of the subjects computed tomography (CT) or magnetic resonance imaging (MRI) using RECIST 1.1 criteria for target lesions. Partial Response is when there is at least 30 percent decrease in sum of the longest diameter of the target lesions. Complete Response is when there is disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm).

  8. Percentage of subjects achieving complete response or partial response based on RECIST 1.1 criteria Part 4 [ Time Frame: Up to 2 years ]
    The objective response rate (complete response and partial response) was determined by the investigator assessment of the subjects CT or MRI using RECIST 1.1 criteria for target lesions. Partial Response is when there is at least 30 percent decrease in sum of the longest diameter of the target lesions. Complete Response is when there is disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm.


Secondary Outcome Measures :
  1. Overall response rate (ORR) based on RECIST 1.1 criteria-Part 1 [ Time Frame: Up to 2 years ]
    ORR is defined as the percentage of subjects with tumor size reduction of a predefined amount and for a minimum time period. Response duration usually is measured from the time of initial response until documented tumor progression. ORR will be evaluated according to RECIST 1.1.

  2. ORR based on RECIST 1.1 criteria-Part 2 [ Time Frame: Up to 2 years ]
    ORR is defined as the percentage of subjects with tumor size reduction of a predefined amount and for a minimum time period. Response duration usually is measured from the time of initial response until documented tumor progression. will be evaluated according to RECIST 1.1.

  3. Number of subjects with progression-free survival (PFS)-Part 3 [ Time Frame: Up to 2 years ]
    PFS is defined as time from the date of first dose to the date of disease progression according to clinical or radiological assessment or death due to any causes, whichever occurs earliest.

  4. Number of subjects with PFS-Part 4 [ Time Frame: Up to 2 years ]
    PFS is defined as time from the date of first dose to the date of disease progression according to clinical or radiological assessment or death due to any causes, whichever occurs earliest.

  5. Number of subjects with overall survival -Part 3 [ Time Frame: Up to 2 years ]
    Overall survival is defined as time from the date of first dose to the date of death due to any cause.

  6. Number of subjects with overall survival -Part 4 [ Time Frame: Up to 2 years ]
    Overall survival is defined as time from the date of first dose to the date of death due to any cause.

  7. Number of subjects with AEs and SAEs-Part 3 [ Time Frame: Up to 2 years ]
    An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

  8. Number of subjects with AEs and SAEs-Part 4 [ Time Frame: Up to 2 years ]
    An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

  9. Number of subjects with AEs and SAEs defined by severity-Part 3 [ Time Frame: Up to 2 years ]
    AE and SAE classified as per severity mild, moderate and severe will be presented.

  10. Number of subjects with AEs and SAEs defined by severity-Part 4 [ Time Frame: Up to 2 years ]
    AE and SAE classified as per severity mild, moderate and severe will be presented.

  11. Area under the plasma drug concentration versus time curve (AUC [0-t]) following single dose of GSK3145095-Part 1 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Blood samples will be collected at the indicated time points for the determination of AUC (0-t) following single dose of GSK3145095.

  12. (AUC 0-t) following single dose of GSK3145095-Part 2 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Blood samples will be collected at the indicated time points for the determination of AUC (0-t) following single dose of GSK3145095.

  13. Area under the concentration-time curve over the dosing interval (AUC [0-tau]) following single dose of GSK3145095-Part 1 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Blood samples will be collected at the indicated time points for the determination of AUC (0-tau) following single dose of GSK3145095.

  14. AUC (0-tau) following single dose of GSK3145095-Part 2 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Blood samples will be collected at the indicated time points for the determination of AUC (0-tau) following single dose of GSK3145095.

  15. Maximum observed plasma drug concentration (Cmax) following single dose of GSK3145095-Part 1 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Blood samples will be collected at the indicated time points for the determination of Cmax following single dose of GSK3145095.

  16. Cmax following single dose of GSK3145095-Part 2 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Blood samples will be collected at the indicated time points for the determination of Cmax following single dose of GSK3145095.

  17. Minimum observed plasma drug concentration (Cmin) following single dose of GSK3145095-Part 1 [ Time Frame: Day 1:24 hours post-dose ]
    Blood samples will be collected at the indicated time points for the determination of Cmin following single dose of GSK3145095.

  18. Cmin following single dose of GSK3145095-Part 2 [ Time Frame: Day 1:24 hours post-dose ]
    Blood samples will be collected at the indicated time points for the determination of Cmin following single dose of GSK3145095.

  19. Time to maximum observed plasma drug concentration (tmax) following single dose of GSK3145095-Part 1 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Blood samples will be collected at the indicated time points for the determination of tmax following single dose of GSK3145095.

  20. tmax following single dose of GSK3145095-Part 2 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Blood samples will be collected at the indicated time points for the determination of tmax following single dose of GSK3145095.

  21. Clearance (CL/F) following single dose of GSK3145095-Part 1 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Blood samples will be collected at the indicated time points for the determination of CL/F following single dose of GSK3145095.

  22. CL/F following single dose of GSK3145095-Part 2 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Blood samples will be collected at the indicated time points for the determination of CL/F following single dose of GSK3145095.

  23. Volume of distribution (V/F) following single dose of GSK3145095-Part 1 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Blood samples will be collected at the indicated time points for the determination of V/F following single dose of GSK3145095.

  24. V/F following single dose of GSK3145095-Part 2 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Blood samples will be collected at the indicated time points for the determination of V/F following single dose of GSK3145095.

  25. Terminal half-life (t1/2) following single dose of GSK3145095-Part 1 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Blood samples will be collected at the indicated time points for the determination of t1/2 following single dose of GSK3145095.

  26. t1/2 following single dose of GSK3145095-Part 2 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Blood samples will be collected at the indicated time points for the determination of t1/2 following single dose of GSK3145095.

  27. AUC (0-t) following repeat dose of GSK3145095-Part 1 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Blood samples will be collected at the indicated time points for the determination of AUC (0-t) following repeat dose of GSK3145095.

  28. AUC (0-t) following repeat dose of GSK3145095-Part 2 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Blood samples will be collected at the indicated time points for the determination of AUC (0-t) following repeat dose of GSK3145095.

  29. AUC (0-tau) following repeat dose of GSK3145095-Part 1 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Blood samples will be collected at the indicated time points for the determination of AUC (0-tau) following repeat dose of GSK3145095.

  30. AUC (0-tau) following repeat dose of GSK3145095-Part 2 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Blood samples will be collected at the indicated time points for the determination of AUC (0-tau) following repeat dose of GSK3145095.

  31. Cmax following repeat dose of GSK3145095-Part 1 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Blood samples will be collected at the indicated time points for the determination of Cmax following repeat dose of GSK3145095.

  32. Cmax following repeat dose of GSK3145095-Part 2 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Blood samples will be collected at the indicated time points for the determination of Cmax following repeat dose of GSK3145095.

  33. Cmin following repeat dose of GSK3145095-Part 1 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Blood samples will be collected at the indicated time points for the determination of Cmin following repeat dose of GSK3145095.

  34. Cmin following repeat dose of GSK3145095-Part 2 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Blood samples will be collected at the indicated time points for the determination of Cmin following repeat dose of GSK3145095.

  35. tmax following repeat dose of GSK3145095-Part 1 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Blood samples will be collected at the indicated time points for the determination of tmax following repeat dose of GSK3145095.

  36. tmax following repeat dose of GSK3145095-Part 2 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Blood samples will be collected at the indicated time points for the determination of tmax following repeat dose of GSK3145095.

  37. CL/F following repeat dose of GSK3145095-Part 1 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Blood samples will be collected at the indicated time points for the determination of CL/F following repeat dose of GSK3145095.

  38. CL/F following repeat dose of GSK3145095-Part 2 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Blood samples will be collected at the indicated time points for the determination of CL/F following repeat dose of GSK3145095.

  39. V/F following repeat dose of GSK3145095-Part 1 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Blood samples will be collected at the indicated time points for the determination of V/F following repeat dose of GSK3145095.

  40. V/F following repeat dose of GSK3145095-Part 2 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Blood samples will be collected at the indicated time points for the determination of V/F following repeat dose of GSK3145095.

  41. t1/2 following repeat dose of GSK3145095-Part 1 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Blood samples will be collected at the indicated time points for the determination of t1/2 following repeat dose of GSK3145095.

  42. t1/2 following repeat dose of GSK3145095-Part 2 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Blood samples will be collected at the indicated time points for the determination of t1/2 following repeat dose of GSK3145095.

  43. Dose proportionality using AUC following single dose of GSK3145095-Part 1 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Dose proportionality will be evaluated for GSK3145095.

  44. Dose proportionality using Cmax following single dose of GSK3145095-Part 1 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Dose proportionality will be evaluated for GSK3145095.

  45. Dose proportionality using AUC following repeat dose of GSK3145095-Part 1 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Dose proportionality will be evaluated for GSK3145095.

  46. Dose proportionality using Cmax following repeat dose of GSK3145095-Part 1 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Dose proportionality will be evaluated for GSK3145095.

  47. Dose proportionality using AUC (0-tau) following single dose of GSK3145095-Part 2 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Dose proportionality will be evaluated for GSK3145095.

  48. Dose proportionality using Cmax following single dose of GSK3145095-Part 2 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Dose proportionality will be evaluated for GSK3145095.

  49. Dose proportionality using AUC (0-tau) following repeat dose of GSK3145095-Part 2 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Dose proportionality will be evaluated for GSK3145095.

  50. Dose proportionality using Cmax following repeat dose of GSK3145095-Part 2 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Dose proportionality will be evaluated for GSK3145095.

  51. Accumulation ratio following repeat dose of GSK3145095-Part 1 [ Time Frame: Days 1: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour; Days 15: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Accumulation ratio will be calculated as AUC(0-tau) at Day 15 divided by AUC(0-tau) at Day 1 for GSK3145095.

  52. Accumulation ratio following repeat dose of GSK3145095-Part 2 [ Time Frame: Days 1: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour; Days 15: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Accumulation ratio will be calculated as AUC(0-tau) at Day 15 divided by AUC(0-tau) at Day 1 for GSK3145095.

  53. Time invariance following repeat dose of GSK3145095-Part 1 [ Time Frame: Days 1: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour; Days 15: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Time invariance will be calculated as calculated as AUC(0-tau) at Day 15 divided by AUC(0-infinity) at Day 1 for GSK3145095.

  54. Time invariance following repeat dose of GSK3145095 of GSK3145095-Part 2 [ Time Frame: Days 1: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour; Days 15: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Time invariance will be calculated as calculated as AUC(0-tau) at Day 15 divided by AUC(0-infinity) at Day 1 for GSK3145095.

  55. Plasma concentration of pembrolizumab -Part 2 [ Time Frame: Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years ]
    Blood samples will be collected at indicated time points for the determination of plasma concentration of pembrolizumab.

  56. Cmax of pembrolizumab-Part 2 [ Time Frame: Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years ]
    Blood samples will be collected at the indicated time points for the determination of Cmax following pembrolizumab.

  57. AUC (0-tau) of pembrolizumab-Part 2 [ Time Frame: Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22 (pre-dose) ]
    Blood samples will be collected at the indicated time points for the determination of AUC (0-tau) following pembrolizumab.

  58. Cmin of pembrolizumab-Part 2 [ Time Frame: Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years ]
    Blood samples will be collected at the indicated time points for the determination of Cmin following pembrolizumab.

  59. AUC (0-t) following single dose of GSK3145095-Part 3 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Blood samples will be collected at the indicated time points for the determination of AUC (0-t) following single dose of GSK3145095.

  60. Cmax following single dose of GSK3145095-Part 3 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Blood samples will be collected at the indicated time points for the determination of Cmax following single dose of GSK3145095.

  61. tmax following single dose of GSK3145095-Part 3 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Blood samples will be collected at the indicated time points for the determination of tmax following single dose of GSK3145095.

  62. t1/2 following single dose of GSK3145095-Part 3 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Blood samples will be collected at the indicated time points for the determination of t1/2 following single dose of GSK3145095.

  63. AUC (0-t) following repeat dose of GSK3145095-Part 3 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Blood samples will be collected at the indicated time points for the determination of AUC(0-t) following repeat dose of GSK3145095.

  64. Cmax following repeat dose of GSK3145095-Part 3 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Blood samples will be collected at the indicated time points for the determination of Cmax following repeat dose of GSK3145095.

  65. tmax following repeat dose of GSK3145095-Part 3 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Blood samples will be collected at the indicated time points for the determination of tmax following repeat dose of GSK3145095.

  66. t1/2 following repeat dose of GSK3145095-Part 3 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Blood samples will be collected at the indicated time points for the determination of t1/2 following repeat dose of GSK3145095.

  67. AUC (0-t) following single dose of pembrolizumab-Part 3 [ Time Frame: Study Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hour after end of infusion ]
    Blood samples will be collected at the indicated time points for the determination of AUC(0-t) following single dose of pembrolizumab.

  68. AUC (0-tau) following single dose of pembrolizumab -Part 3 [ Time Frame: Study Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hour after end of infusion ]
    Blood samples will be collected at the indicated time points for the determination of AUC(0-tau) following single dose of pembrolizumab.

  69. Cmax following single dose of pembrolizumab -Part 3 [ Time Frame: Study Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hour after end of infusion ]
    Blood samples will be collected at the indicated time points for the determination of Cmax following single dose of pembrolizumab.

  70. tmax following single dose of pembrolizumab -Part 3 [ Time Frame: Study Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hour after end of infusion ]
    Blood samples will be collected at the indicated time points for the determination of tmax following single dose of pembrolizumab.

  71. t1/2 following single dose of pembrolizumab -Part 3 [ Time Frame: Study Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hour after end of infusion ]
    Blood samples will be collected at the indicated time points for the determination of t1/2 following single dose of pembrolizumab.

  72. AUC (0-t) following repeat dose of pembrolizumab -Part 3 [ Time Frame: Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years ]
    Blood samples will be collected at the indicated time points for the determination of AUC(0-t) following repeat dose of pembrolizumab.

  73. AUC (0-tau) following repeat dose of pembrolizumab -Part 3 [ Time Frame: Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years ]
    Blood samples will be collected at the indicated time points for the determination of AUC(0-tau) following repeat dose of pembrolizumab.

  74. Cmax following repeat dose of pembrolizumab -Part 3 [ Time Frame: Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years ]
    Blood samples will be collected at the indicated time points for the determination of Cmax following repeat dose of pembrolizumab.

  75. tmax following repeat dose of pembrolizumab -Part 3 [ Time Frame: Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years ]
    Blood samples will be collected at the indicated time points for the determination of tmax following repeat dose of pembrolizumab.

  76. t1/2 following repeat dose of pembrolizumab -Part 3 [ Time Frame: Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years ]
    Blood samples will be collected at the indicated time points for the determination of t1/2 following repeat dose of pembrolizumab.

  77. Dose proportionality using AUC following single dose of GSK3145095-Part 3 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Dose proportionality will be evaluated for GSK3145095.

  78. Dose proportionality using Cmax following single dose of GSK3145095-Part 3 [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours ]
    Dose proportionality will be evaluated for GSK3145095.

  79. Dose proportionality using AUC (0-tau) following repeat dose of GSK3145095-Part 3 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Dose proportionality will be evaluated for GSK3145095.

  80. Dose proportionality using Cmax following repeat dose of GSK3145095-Part 3 [ Time Frame: Days 15,16: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Dose proportionality will be evaluated for GSK3145095.

  81. Accumulation ratio following repeat dose of GSK3145095-Part 3 [ Time Frame: Days 1: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour; Days 15: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose ]
    Accumulation ratio will be calculated as AUC(0-tau) at Day 15 divided by AUC(0-tau) at Day 1 for GSK3145095.

  82. Time invariance following repeat dose of GSK3145095-Part 3 [ Time Frame: Days 1: Pre - dose ,0.5,1,1.5,2,3,4,6,8,10,24 hour; Days 15: Pre - dose ,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose ; Day 15:0.5,1,2,3,6,8 hour post evening dose ]
    Time invariance will be calculated as calculated as AUC(0-tau) at Day 15 divided by AUC(0-infinity) at Day 1 for GSK3145095.

  83. Dose proportionality using AUC following single dose of pembrolizumab-Part 3 [ Time Frame: Study Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hour after end of infusion ]
    Dose proportionality will be evaluated for pembrolizumab.

  84. Dose proportionality using Cmax following single dose of pembrolizumab-Part 3 [ Time Frame: Study Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hour after end of infusion ]
    Dose proportionality will be evaluated for pembrolizumab.

  85. Dose proportionality using AUC (0-tau) following repeat dose of pembrolizumab-Part 3 [ Time Frame: Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years. ]
    Dose proportionality will be evaluated for pembrolizumab.

  86. Dose proportionality using Cmax following repeat dose of pembrolizumab-Part 3 [ Time Frame: Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years. ]
    Dose proportionality will be evaluated for pembrolizumab.

  87. Accumulation ratio following repeat dose of pembrolizumab-Part 3 [ Time Frame: Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years ]
    Accumulation ratio will be calculated as AUC(0-tau) at Day 15 divided by AUC(0-tau) at Day 1 for pembrolizumab.

  88. Time invariance following repeat dose of pembrolizumab-Part 3 [ Time Frame: Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years ]
    Time invariance will be calculated as calculated as AUC(0-tau) at Day 15 divided by AUC(0-infinity) at Day 1 for pembrolizumab.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must provide signed, written informed consent.
  • Male and female subjects, age >=18 years (at the time consent is obtained). a) Male subjects are eligible to participate if they agree to the following during the study treatment period and for at least 15 days (Part 1) and 120 days (Parts 2-4) after the last dose of study treatment: Refrain from donating sperm, be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or must agree to use contraception/barrier: male condom and female partner to use an additional highly effective contraceptive method with a failure rate of <1 percent per year. b) female subjects are eligible to participate if they are not either pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP), is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1 percent per year), with low user dependency during the study treatment period and for at least 15 days (Part 1) and 120 days (Parts 2-4) after the last dose of study treatment and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment. Hormonal contraception may be susceptible to interaction with the study drug, which may reduce the efficacy of the contraceptive method. Therefore, a barrier method is also required for subjects using a hormonal option (including hormonal intrauterine device [IUD], oral contraceptive pills/ patch/ vaginal inserts, and hormonal implants) and both highly effective methods of contraception should be utilized during the treatment period and for at least 15 days (Part 1) and 120 days (Parts 2-4) after the last dose of study treatment.If a highly effective non-hormonal method is used, then only one method of contraception is required (by a female participant or partner of a male participant; in either situation the male partner must still use a male condom in addition) during the treatment period and for at least 15 days (Part 1) and 120 days (Parts 2-4) after the last dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) as required by local regulations) within 24 hours before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the subject must be excluded from participation if the serum pregnancy result is positive. If the subject hasn't been on an acceptable method of contraception for at least 2 weeks prior to start of therapy, pregnancy testing must be done weekly for the first month of treatment. Additional requirements for pregnancy testing during and after study treatment. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • Histological documentation of locally advanced, recurrent or PDAC (Part 1), non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), or melanoma (Part 2) that has progressed after standard therapy appropriate for the specific tumor type, or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate. Subjects should have received at least one, but not more than 2 prior lines of therapy for advanced disease including both standards of care and investigational therapies. Subjects whose cancers harbor molecular alterations for which targeted therapy is standard of care should have received health authority-approved appropriate targeted therapy for their tumor types before enrollment.
  • All subjects in Parts 1 and 2 must consent to provide a fresh biopsy during screening of a primary tumor lesion or from other metastases (e.g. liver, lung, etc.), and a second biopsy after approximately 5 weeks of treatment.
  • Measurable disease per RECIST version 1.1. Palpable lesions that are not measurable by radiologic or photographic evaluations may not be utilized as the only measurable lesion. Subjects are encouraged to provide a pre-Baseline scan (within 24 weeks before the Baseline scan) to support exploratory investigation of tumor growth kinetics.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1.
  • Life expectancy of at least 12 weeks.
  • Adequate organ function.
  • QT duration corrected for heart rate by Fridericia's formula (QTcF) <450 milliseconds (or QTcF <480 milliseconds for subjects with bundle branch block).

Exclusion Criteria:

  • Prior treatment with the following agents: Agents affecting tumor associated macrophage function or number, including but not limited to inhibitors of Receptor-interacting protein 1 (RIP1), Receptor-interacting protein 3 (RIP3), Colony stimulating factor 1 receptor (CSFR-1), C-C chemokine receptor type 2 (CCR2), and Cluster of differentiation 40 (CD40). Other anticancer therapy, including chemotherapy, targeted therapy, and biological therapy, within 14 days or 5 half-lives (from last dose of prior treatment to first dose of GSK3145095), whichever is shorter. Prior radiation therapy is permissible if at least one non-irradiated measurable lesion is available for assessment via RECIST version 1.1. No washout after palliative radiation is required. Investigational therapy within 14 days or 5 half-lives (from last dose of prior treatment to first dose of GSK3145095), whichever is shorter.
  • Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.
  • Toxicity from previous treatment: Subjects whose toxicity related to prior treatment has not resolved to <=Grade 1 (except alopecia, hearing loss, Grade <=2 neuropathy or endocrinopathy managed with replacement therapy) are not eligible.
  • Malignancy other than disease under study, except as noted: Subject with any other malignancy from which the subject has been disease-free for more than 2 years and, in the opinion of the principal investigators and GlaxoSmithKline (GSK) Medical Monitor, will not affect the evaluation of the effects of this clinical trial treatment on currently targeted malignancy, can be included in this clinical trial.
  • Major surgery <=4 weeks before the first dose of study treatment. Subjects must have also fully recovered from any surgery (major or minor) and/or its complications before initiating study treatment.
  • Active autoimmune disease that has required systemic treatment within the last 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Concurrent medical condition requiring the use of systemic immunosuppressive medications within 28 days before the first dose of study treatment. Physiologic doses of corticosteroids for treatment of endocrinopathies or steroids with minimal systemic absorption, including topical, inhaled, or intranasal corticosteroids, may be continued if the subject is on a stable dose.
  • Active infection (including active herpes zoster infection), known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen or hepatitis C.
  • Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per investigator assessment).
  • Known current drug or alcohol abuse.
  • Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction.
  • Receipt of any live vaccine within 4 weeks before starting study treatment.
  • Recent history of allergen desensitization therapy within 4 weeks before starting study treatment (applies to subjects enrolled in Parts 2 and 3 only).
  • History or evidence of cardiovascular risk including any of the following: recent (within the past 6 months) history of serious uncontrolled cardiac arrhythmia or clinically significant electrocardiogram (ECG) abnormalities including second degree (Type II) or third degree atrioventricular block. Documented cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting, or bypass grafting within the past 6 months before beginning screening. Documented congestive heart failure (Class II, III, or IV) as defined by the New York Heart Association functional classification system. Recent (within the past 6 months) history of symptomatic pericarditis.
  • Current or history of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia.
  • History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Recent history (within 14 days) of ascites or pleural effusions requiring drainage.
  • Any serious and/or unstable pre-existing medical, psychiatric disorder, or other condition that could interfere with the subjects safety, obtaining informed consent, or compliance to the study procedures.
  • Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial, unless prospective Institutional Review Board (IRB) approval (by chair or designee) is given allowing exception to this criterion for a specific subject.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681951


Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Sponsors and Collaborators
GlaxoSmithKline
Parexel
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03681951     History of Changes
Other Study ID Numbers: 205013
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
Advanced solid tumors
Anticancer Agents
FTIH
Pembrolizumab
Rip1K
GSK3145095
Dose Escalation
Immunotherapy resistance
Dose Expansion
RECIST 1.1
Innate immunity

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pembrolizumab
Antineoplastic Agents