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Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04446351
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : June 5, 2023
Sponsor:
Collaborators:
23andMe, Inc.
iTeos Therapeutics
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
This first-time-in-human (FTIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of escalating doses of GSK6097608 given as monotherapy and in combination with dostarlimab in participants with advanced solid tumors. In addition, dostarlimab will be given as monotherapy and in combination with GSK6097608 and with GSK4428859A (EOS884448) in Japanese and Chinese participants and dostarlimab will be given in combination with cobolimab in Japanese participants. Drug name mentioned as GSK4428859A and EOS884448 are interchangeable for the same compound. In the rest of the document, the drug will be referred to as GSK4428859A (EOS884448).

Condition or disease Intervention/treatment Phase
Neoplasms Drug: GSK6097608 Drug: Dostarlimab Drug: GSK4428859A (EOS884448) Drug: Cobolimab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Participants will receive treatment in different dose escalation arms of the study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 First-Time-in-Human, Open-Label Study of GSK6097608 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors
Actual Study Start Date : June 25, 2020
Estimated Primary Completion Date : April 11, 2025
Estimated Study Completion Date : April 11, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Dostarlimab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Participants receiving GSK6097608 monotherapy (Arm A)
Participants will be administered an intravenous (IV) infusion of GSK6097608 every 3 weeks as monotherapy in escalating doses.
 Drug: GSK6097608
GSK6097608 will be administered as an IV infusion.
Experimental: Participants receiving GSK6097608 plus dostarlimab (Arm B)
Participants will be administered IV infusion of GSK6097608 every 3 weeks in escalating doses followed by dostarlimab.
 Drug: GSK6097608
GSK6097608 will be administered as an IV infusion.

Drug: Dostarlimab
Dostarlimab will be administered as an IV infusion.
Experimental: Participants receiving dostarlimab monotherapy (Arm D)
Participants will be administered an IV infusion of dostarlimab monotherapy (1 cohort will receive dostarlimab every 3 weeks and 1 cohort will receive dostarlimab every 6 weeks).
 Drug: Dostarlimab
Dostarlimab will be administered as an IV infusion.
Experimental: Participants receiving dostarlimab plus GSK4428859A (EOS884448) (Arm E)
Participants will be administered IV infusions of dostarlimab followed by of GSK4428859A (EOS884448), every 3 weeks.
 Drug: Dostarlimab
Dostarlimab will be administered as an IV infusion.

Drug: GSK4428859A (EOS884448)
GSK4428859A (EOS884448) will be administered as an IV infusion.
Experimental: Participants receiving dostarlimab plus GSK4428859A (EOS884448) plus GSK6097608 (Arm F)
Participants will be administered an IV infusion of dostarlimab followed GSK4428859A (EOS884448) followed by GSK6097608 every 3 weeks.
 Drug: GSK6097608
GSK6097608 will be administered as an IV infusion.

Drug: Dostarlimab
Dostarlimab will be administered as an IV infusion.

Drug: GSK4428859A (EOS884448)
GSK4428859A (EOS884448) will be administered as an IV infusion.
Experimental: Participants receiving dostarlimab plus cobolimab (Arm G)
Participants will be administered an IV infusion of cobolimab followed by dostarlimab
 Drug: Dostarlimab
Dostarlimab will be administered as an IV infusion.

Drug: Cobolimab
Cobolimab will be administered as an IV infusion.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Up to Day 21 ]
  2. Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Number of participants with clinically significant changes in laboratory parameters, vital signs, and 12-lead electrocardiogram (ECG) findings [ Time Frame: Up to 2 years ]
  2. Number of participants with dose reductions or delay [ Time Frame: Up to 2 years ]
  3. Number of participants withdrawn due to AEs [ Time Frame: Up to 2 years ]
  4. Overall response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Up to 2 years ]
  5. Arms D, E, F, G: ORR based on modified Response Evaluation Criteria in Solid Tumors (iRECIST) [ Time Frame: Up to 2 years ]
  6. Arms D, E, F, G: Disease Control Rate (DCR) based on RECIST 1.1 [ Time Frame: Up to 2 years ]
  7. Arms D, E, F, G: DCR based on iRECIST [ Time Frame: Up to 2 years ]
  8. Arms D, E, F, G: Time to response (TTR) based on RECIST 1.1 [ Time Frame: Up to 2 years ]
  9. Arms D, E, F, G: TTR based on iRECIST [ Time Frame: Up to 2 years ]
  10. Arms D, E, F, G: Duration of response (DOR) based on RECIST 1.1 [ Time Frame: Up to 2 years ]
  11. Arms D, E, F, G: DOR based on iRECIST [ Time Frame: Up to 2 years ]
  12. Arms D, E, F, G: Progression-free survival (PFS) based on RECIST 1.1 [ Time Frame: Up to 2 years ]
  13. Arms D, E, F, G: PFS based on iRECIST [ Time Frame: Up to 2 years ]
  14. Arms A, B, F: Number of participants with positive anti-drug antibodies (ADAs) against GSK6097608 [ Time Frame: Up to 2 years ]
  15. Arms A, B, F: Titers of ADAs against GSK6097608 [ Time Frame: Up to 2 years ]
  16. Arms B, D, E, F, G: Number of participants with positive ADAs against dostarlimab [ Time Frame: Up to 2 years ]
  17. Arms B, D, E, F, G: Titers of ADAs against dostarlimab [ Time Frame: Up to 2 years ]
  18. Arms E, F: Number of participants with positive ADAs against GSK4428859A (EOS884448) [ Time Frame: Up to 2 years ]
  19. Arms E, F: Titers of ADAs against GSK4428859A (EOS884448) [ Time Frame: Up to 2 years ]
  20. Arm G: Number of participants with positive ADAs against cobolimab [ Time Frame: Up to 2 years ]
  21. Arm G: Titers of ADAs against cobolimab [ Time Frame: Up to 2 years ]
  22. Arms A, B, F: Maximum observed concentration (Cmax) for GSK6097608 [ Time Frame: Up to 2 years ]
  23. Arms A, B, F: Minimum observed concentration (Cmin) for GSK6097608 [ Time Frame: Up to 2 years ]
  24. Arms A, B, F: Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC[0-infinity]) for GSK6097608 [ Time Frame: Up to 2 years ]
  25. Arms A, B, F: Area under the plasma concentration-time curve from time zero to time (AUC[0-t]) for GSK6097608 [ Time Frame: Up to 2 years ]
  26. Arms A, B, F: Apparent terminal phase half-life (t1/2) for GSK6097608 [ Time Frame: Up to 2 years ]
  27. Arms B, D, E, F, G: Cmax for dostarlimab [ Time Frame: Up to 2 years ]
  28. Arms B, D, E, F, G: Cmin for dostarlimab [ Time Frame: Up to 2 years ]
  29. Arms B, D, E, F, G: AUC(0-infinity) for dostarlimab [ Time Frame: Up to 2 years ]
  30. Arms B, D, E, F, G: AUC(0-t) for dostarlimab [ Time Frame: Up to 2 years ]
  31. Arms B, D, E, F, G: t1/2 for dostarlimab [ Time Frame: Up to 2 years ]
  32. Arms E, F: Cmax for GSK4428859A (EOS884448) [ Time Frame: Up to 2 years ]
  33. Arms E, F: Cmin for GSK4428859A (EOS884448) [ Time Frame: Up to 2 years ]
  34. Arms E, F: AUC(0-infinity) for GSK4428859A (EOS884448) [ Time Frame: Up to 2 years ]
  35. Arms E, F: AUC(0-t) for GSK4428859A (EOS884448) [ Time Frame: Up to 2 years ]
  36. Arms E, F: t1/2 for GSK4428859A (EOS884448) [ Time Frame: Up to 2 years ]
  37. Arm G: Cmax for cobolimab [ Time Frame: Up to 2 years ]
  38. Arm G: Cmin for cobolimab [ Time Frame: Up to 2 years ]
  39. Arm G: AUC(0-infinity) for cobolimab [ Time Frame: Up to 2 years ]
  40. Arm G: AUC(0-t) for cobolimab [ Time Frame: Up to 2 years ]
  41. Arm G: t1/2 for cobolimab [ Time Frame: Up to 2 years ]

Eligibility Criteria
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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.


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

Inclusion Criteria:

  • Adults 18 years of age or older (or >=20 years of age in Arm-A Japan, Arm-D Japan, Arm E-Japan, Arm F-Japan, and Arm G-Japan);
  • Female participants of childbearing potential must agree to use a highly effective form of contraception;
  • Histological or cytological documentation of locally advanced, recurrent, or metastatic solid malignancy;
  • Disease that has progressed after standard therapy for the specific tumor type, or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate, or if no further standard therapy exists;
  • Participants in a PK/PD cohort must provide fresh tumor biopsies.
  • Eastern cooperative oncology group (ECOG) performance status (PS) 0 to 1
  • Life expectancy of at least 12 weeks.
  • Adequate organ function as determined by laboratory assessments.
  • Adequate cardiac ejection fraction as measured by echocardiogram.
  • Arm A-Japan, Arm D-Japan, Arm E-Japan, Arm F-Japan, and Arm G-Japan only: lives in Japan and is racially Japanese, defined as all biological grandparents being Japanese.
  • Arm A-China, Arm B-China, Arm D-China, Arm E-China and Arm F-China only: is of Chinese descent and lives in China.
  • Arm D, Arm E, Arm F, and Arm G only: has been deemed suitable for assigned treatment based on assessment by the investigator.

Exclusion Criteria:

  • Prior anti-cancer treatment including investigational agents, immune checkpoint inhibitors, chemotherapy, targeted therapy, and biological therapy: within 4 weeks or 5 half-lives of the drug, whichever is shorter.
  • Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation.
  • Toxicity from previous anticancer treatment, including; greater than or equal to (>=) Grade 3 immune-mediated toxicity considered related to prior immunotherapy and that led to treatment discontinuation; or toxicity related to prior treatment that has not resolved; or myocarditis of any grade considered related to prior immuno-oncology therapy that led to treatment discontinuation.
  • Known additional malignancy that progressed or required active treatment within the last 2 years.
  • Uncontrolled or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Active autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years.
  • Concurrent medical condition requiring the use of systemic immunosuppressive treatment.
  • Cirrhosis or current unstable liver or biliary disease per investigator assessment.
  • Active infection requiring systemic treatment, known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
  • Prolonged QT as measured by electrocardiogram.
  • Allergen desensitization therapy within 4 weeks of starting study intervention.
  • History of hypersensitivity to any of the study interventions or their excipients.
  • History or evidence of significant cardiovascular (CV) risk.
  • Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions.
  • History of idiopathic pulmonary fibrosis; interstitial lung disease; organizing pneumonia; noninfectious pneumonitis that required steroids, or evidence of active, noninfectious pneumonitis.
  • Pregnant or lactating woman.
  • Receipt of live vaccine within 30 days of the start of study intervention.
  • Receipt of transfusion of blood products or administration of colony-stimulating factors within 14 days before the first dose of study intervention.
  • Major surgery less than 4 weeks before the first dose of study intervention.
  • Known drug or alcohol abuse.
Contacts and Locations
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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): NCT04446351


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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United States, California
GSK Investigational Site Recruiting
Los Angeles, California, United States, 90025
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Omid Hamid         
United States, Massachusetts
GSK Investigational Site Recruiting
Boston, Massachusetts, United States, 02215
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Frank Stephen Hodi         
United States, Texas
GSK Investigational Site Recruiting
Dallas, Texas, United States, 75230
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Reva Elaine Schneider         
GSK Investigational Site Recruiting
Houston, Texas, United States, 77030-4009
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jordi Rodón Ahnert         
GSK Investigational Site Recruiting
San Antonio, Texas, United States, 78229
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Drew W Rasco         
Canada, Ontario
GSK Investigational Site Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Scott A Laurie         
GSK Investigational Site Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Lillian Siu         
Japan
GSK investigational Site Recruiting
Chiba, Japan, 277-8577
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Yoshitake Zenke         
GSK Investigational Site Recruiting
Tokyo, Japan, 104-0045
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Noboru Yamamoto         
Korea, Republic of
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 03080
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Dong Wan Kim         
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 06351
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Myung-Ju Ahn         
Sponsors and Collaborators
GlaxoSmithKline
23andMe, Inc.
iTeos Therapeutics
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04446351    
Other Study ID Numbers: 212214
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: June 5, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications
Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months
URL: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
GSK6097608
Dostarlimab
Dose escalation
Pharmacokinetics
Pharmacodynamics
 Advanced solid tumors
First-time-in-human
GSK4428859A
EOS884448
Cobolimab
Additional relevant MeSH terms:
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Dostarlimab
Antineoplastic Agents