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The Safety and Pharmacokinetics Preliminary Efficacy of IMP7068 in Patients With Advanced Solid Tumors (WEE1)

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: NCT04768868
Recruitment Status : Recruiting
First Posted : February 24, 2021
Last Update Posted : November 24, 2021
Sponsor:
Collaborator:
Covance
Information provided by (Responsible Party):
Impact Therapeutics, Inc.

Brief Summary:
A Phase 1 Dose Escalation and Expansion Study of IMP7068 Monotherapy in Advanced Solid Tumors

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: IMP7068 Phase 1

Detailed Description:

This is A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of the WEE1 Inhibitor IMP7068 Monotherapy in Patients with Advanced Solid Tumors

The study will include a dose-escalation stage and a dose-expansion stage. The dose-escalation stage is designed to determine the maximum tolerated dose (MTD) and select recommended Phase 2 dose (RP2D) of IMP7068 monotherapy. The dose-expansion stage will be conducted with RP2D to further evaluate the preliminary anti-tumor activity, safety and tolerability.

A total of approximately 150 patients will be enrolled in the study.

Approximately 50 patients will be enrolled into Part 1 dose escalation of IMP7068 monotherapy. A total of 100 patients each with advanced solid tumor will be evaluated in Part 2 dose-expansion of IMP7068 monotherapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description:

The dose schedules will be explored in this study (described below):

Dose Schedule: IMP7068 administered QD on Days 1-3, Days 8-10 and Days 15-17 on a 21-day cycle.

The other Dose Schedules may be explored according to SMC decision.

The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage. Approximately100 patients each with advanced solid tumor who has exhausted available treatment options with respective biomarker(s) determined by central laboratory will be evaluated. Single dosing will not be performed in the dose-expansion stage of the study.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of the WEE1 Inhibitor IMP7068 Monotherapy in Patients With Advanced Solid Tumors
Actual Study Start Date : February 25, 2021
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : August 30, 2023


Arm Intervention/treatment
IMP7068

Part 1: Dose Escalation

The study will begin with open-label dose escalation in IMP7068 monotherapy treatment to determine the Maximum tolerated dose (MTD)

Part 2: Dose Expansion The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage. A total of 100 patients each with advanced solid tumor who has exhausted available treatment options will be evaluated.

Drug: IMP7068
To evaluate the safety tolerability, pharmacokinetics, and anti-tumor activity of the WEE1 inhibitor IMP7068 monotherapy in patients with advanced solid tumors




Primary Outcome Measures :
  1. Part 1 Dose Escalation: Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: Day 1 through to 30 days after last dose (approximately 4 cycles (84 days plus 30 day follow-up )); Each cycle is 21 days ]
  2. Part 1 Dose Escalation: Severity of treatment emergent adverse events (TEAEs), according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0 [ Time Frame: Day 1 through to 30 days after last dose (approximately 4 cycles (84 days plus 30 day follow-up )); Each cycle is 21 days ]
  3. Part 1 Dose Escalation: Number of patients with changes in Vital Signs [ Time Frame: Screening (Day -28) through 30 days after last dose, estimated to be 5 months ]
  4. Part 1 Dose Escalation: Number of patients with changes in Physical Examination [ Time Frame: Screening (Day -28) through 30 days after last dose, estimated to be 5 months ]
  5. Part 1 Dose Escalation: Number of patients with changes in single and triplicate 12-lead Electrocardiogram (ECG) [ Time Frame: Screening (Day -28) through 30 days after last dose, estimated to be 5 months ]
  6. Part 1 Dose Escalation: Number of patients with changes in Laboratory Test - Serum chemistry [ Time Frame: Screening (Day -28) through 30 days after last dose, estimated to be 5 months ]
  7. Part 1 Dose Escalation: Number of patients with changes in Laboratory Test - Hematology [ Time Frame: Screening (Day -28) through 30 days after last dose, estimated to be 5 months ]
  8. Part 1 Dose Escalation: Number of patients with changes in Laboratory Test - Coagulation parameters [ Time Frame: Screening (Day -28) through 30 days after last dose, estimated to be 5 months ]
  9. Part 1 Dose Escalation: Number of patients with changes in Laboratory Test - Urinalysis [ Time Frame: Screening (Day -28) through 30 days after last dose, estimated to be 5 months ]
  10. Part 1 Dose Escalation: Recommended Phase 2 Dose (RP2D) of IMP7068 monotherapy [ Time Frame: Day 1 through to start of dose expansion phase (approximately 1 year) ]
    Recommended Phase 2 Dose (RP2D) of IMP7068 monotherapy (selected by the safety monitoring committee (SMC) based on pharmacokinetics, target saturation at steady state, pharmacodynamics, safety, tolerability and preliminary anti-tumor effects of the dose range studied)

  11. Part 2 Dose Expansion: Overall Response Rate (ORR) [ Time Frame: Day 1 through 30 days after last dose, estimated to be 5 months ]
    Overall Response Rate (ORR) for all cohorts (percentage of patients who had a best response rating of complete response (CR) and partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, which was maintained ≥4 weeks)


Secondary Outcome Measures :
  1. Part 1 Dose Escalation: Pharmacokinetic parameter derived from plasma IMP7068 concentration following single oral doses for maximum observed plasma drug concentration (Cmax) [ Time Frame: Time Frame: Single-Dose Phase: Day 1, 2, 3 and 4 ]
  2. Part 1 Dose Escalation: Pharmacokinetic parameter derived from plasma IMP7068 concentration following single oral doses for time to reach Cmax (Tmax) [ Time Frame: Time Frame: Single-Dose Phase: Day 1, 2, 3 and 4 ]
  3. Part 1 Dose Escalation: Pharmacokinetic parameter derived from plasma IMP7068 concentration following single oral doses for area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) [ Time Frame: Time Frame: Single-Dose Phase: Day 1, 2, 3 and 4 ]
  4. Part 1 Dose Escalation: Pharmacokinetic parameter derived from plasma IMP7068 concentration following single oral doses for area under the plasma concentration-time curve from time zero to time tau (AUC0-tau) [ Time Frame: Time Frame: Single-Dose Phase: Day 1, 2, 3 and 4 ]
  5. Part 1 Dose Escalation: Pharmacokinetic parameter derived from plasma IMP7068 concentration following single oral doses dose-normalized Cmax (Cmax [dn]) [ Time Frame: Time Frame: Single-Dose Phase: Day 1, 2, 3 and 4 ]
  6. Part 1 Dose Escalation: Pharmacokinetic parameter derived from plasma IMP7068 concentration following single oral doses for dose-normalized AUC0-tau (AUC0-tau [dn]) [ Time Frame: Time Frame: Single-Dose Phase: Day 1, 2, 3 and 4 ]
  7. Part 1 Dose Escalation: If the data are available, Pharmacokinetic parameter derived from plasma IMP7068 concentration following single oral doses area under the plasma concentration time curve from time zero to infinity (AUC0-inf) [ Time Frame: Time Frame: Single-Dose Phase: Day 1, 2, 3 and 4 ]
  8. Part 1 Dose Escalation: If the data are available, Pharmacokinetic parameter derived from plasma IMP7068 concentration following single oral doses terminal elimination half life (t1/2) [ Time Frame: Time Frame: Single-Dose Phase: Day 1, 2, 3 and 4 ]
  9. Part 1 Dose Escalation: If the data are available, Pharmacokinetic parameter derived from plasma IMP7068 concentration following single oral doses apparent clearance (CL/F) [ Time Frame: Time Frame: Single-Dose Phase: Day 1, 2, 3 and 4 ]
  10. Part 1 Dose Escalation: If the data are available, Pharmacokinetic parameter derived from plasma IMP7068 concentration following single oral doses apparent volume of distribution (Vz/F) [ Time Frame: Time Frame: Single-Dose Phase: Day 1, 2, 3 and 4 ]
  11. Part 1 Dose Escalation: Pharmacokinetic parameter derived from plasma IMP7068 concentration following repeated oral doses for Cmax [ Time Frame: Repeat-Dose Schedule 1 and Schedule 2: Each Cycle = 21 Days; Cycle 1 Day 1,2, 3, 4, 5, 6 and 8, Cycle 2 Day 1 and Cycle 3 Day 1; Repeat Dose Schedule 3: Cycle 1 Day 1, 2, 3, 4, 5 and 8, Cycle 2 Day 1 and Cycle 3 Day 1 ]
  12. Part 1 Dose Escalation: Pharmacokinetic parameter derived from plasma IMP7068 concentration following repeated oral doses for Tmax [ Time Frame: Repeat-Dose Schedule 1 and Schedule 2: Each Cycle = 21 Days; Cycle 1 Day 1,2, 3, 4, 5, 6 and 8, Cycle 2 Day 1 and Cycle 3 Day 1; Repeat Dose Schedule 3: Cycle 1 Day 1, 2, 3, 4, 5 and 8, Cycle 2 Day 1 and Cycle 3 Day 1 ]
  13. Part 1 Dose Escalation: Pharmacokinetic parameters derived from plasma IMP7068 concentration following repeated oral doses for AUC0-last [ Time Frame: Repeat-Dose Schedule 1 and Schedule 2: Each Cycle = 21 Days; Cycle 1 Day 1,2, 3, 4, 5, 6 and 8, Cycle 2 Day 1 and Cycle 3 Day 1; Repeat Dose Schedule 3: Cycle 1 Day 1, 2, 3, 4, 5 and 8, Cycle 2 Day 1 and Cycle 3 Day 1 ]
  14. Part 1 Dose Escalation: Pharmacokinetic parameter derived from plasma IMP7068 concentration following repeated oral doses for AUC0-tau [ Time Frame: Repeat-Dose Schedule 1 and Schedule 2: Each Cycle = 21 Days; Cycle 1 Day 1,2, 3, 4, 5, 6 and 8, Cycle 2 Day 1 and Cycle 3 Day 1; Repeat Dose Schedule 3: Cycle 1 Day 1, 2, 3, 4, 5 and 8, Cycle 2 Day 1 and Cycle 3 Day 1 ]
  15. Part 1 Dose Escalation: Pharmacokinetic parameter derived from plasma IMP7068 concentration following repeated oral doses for minimum plasma concentration during the dosing interval (Cmin) [ Time Frame: Repeat-Dose Schedule 1 and Schedule 2: Each Cycle = 21 Days; Cycle 1 Day 1,2, 3, 4, 5, 6 and 8, Cycle 2 Day 1 and Cycle 3 Day 1; Repeat Dose Schedule 3: Cycle 1 Day 1, 2, 3, 4, 5 and 8, Cycle 2 Day 1 and Cycle 3 Day 1 ]
  16. Part 1 Dose Escalation: Pharmacokinetic parameter derived from plasma IMP7068 concentration following repeated oral doses for observed accumulation ratio for Cmax (Rac_Cmax) [ Time Frame: Repeat-Dose Schedule 1 and Schedule 2: Each Cycle = 21 Days; Cycle 1 Day 1,2, 3, 4, 5, 6 and 8, Cycle 2 Day 1 and Cycle 3 Day 1; Repeat Dose Schedule 3: Cycle 1 Day 1, 2, 3, 4, 5 and 8, Cycle 2 Day 1 and Cycle 3 Day 1 ]
  17. Part 1 Dose Escalation: Pharmacokinetic parameter derived from plasma IMP7068 concentration following repeated oral doses for observed accumulation ratio for AUC0-tau (Rac_AUC0-tau) [ Time Frame: Repeat-Dose Schedule 1 and Schedule 2: Each Cycle = 21 Days; Cycle 1 Day 1,2, 3, 4, 5, 6 and 8, Cycle 2 Day 1 and Cycle 3 Day 1; Repeat Dose Schedule 3: Cycle 1 Day 1, 2, 3, 4, 5 and 8, Cycle 2 Day 1 and Cycle 3 Day 1 ]
  18. Part 1 Dose Escalation: Pharmacokinetic parameter derived from plasma IMP7068 concentration following repeated oral doses for observed accumulation ratio for Cmax (dn) [ Time Frame: Repeat-Dose Schedule 1 and Schedule 2: Each Cycle = 21 Days; Cycle 1 Day 1,2, 3, 4, 5, 6 and 8, Cycle 2 Day 1 and Cycle 3 Day 1; Repeat Dose Schedule 3: Cycle 1 Day 1, 2, 3, 4, 5 and 8, Cycle 2 Day 1 and Cycle 3 Day 1 ]
  19. Part 1 Dose Escalation: Pharmacokinetic parameter derived from plasma IMP7068 concentration following repeated oral doses for observed accumulation ratio for AUC0-tau (dn) [ Time Frame: Repeat-Dose Schedule 1 and Schedule 2: Each Cycle = 21 Days; Cycle 1 Day 1,2, 3, 4, 5, 6 and 8, Cycle 2 Day 1 and Cycle 3 Day 1; Repeat Dose Schedule 3: Cycle 1 Day 1, 2, 3, 4, 5 and 8, Cycle 2 Day 1 and Cycle 3 Day 1 ]
  20. Part 1 Dose Escalation: If the data are available, Pharmacokinetic parameter derived from plasma IMP7068 concentration following repeated oral doses terminal elimination half life (t1/2) [ Time Frame: Repeat-Dose Schedule 1 and Schedule 2: Each Cycle = 21 Days; Cycle 1 Day 1,2, 3, 4, 5, 6 and 8, Cycle 2 Day 1 and Cycle 3 Day 1; Repeat Dose Schedule 3: Cycle 1 Day 1, 2, 3, 4, 5 and 8, Cycle 2 Day 1 and Cycle 3 Day 1 ]
  21. Part 1 Dose Escalation: If the data are available, Pharmacokinetic parameter derived from plasma IMP7068 concentration following repeated oral doses apparent clearance (CL/F) [ Time Frame: Repeat-Dose Schedule 1 and Schedule 2: Each Cycle = 21 Days; Cycle 1 Day 1,2, 3, 4, 5, 6 and 8, Cycle 2 Day 1 and Cycle 3 Day 1; Repeat Dose Schedule 3: Cycle 1 Day 1, 2, 3, 4, 5 and 8, Cycle 2 Day 1 and Cycle 3 Day 1 ]
  22. Part 1 Dose Escalation: If the data are available, Pharmacokinetic parameter derived from plasma IMP7068 concentration following repeated oral doses apparent volume of distribution (Vz/F) [ Time Frame: Repeat-Dose Schedule 1 and Schedule 2: Each Cycle = 21 Days; Cycle 1 Day 1,2, 3, 4, 5, 6 and 8, Cycle 2 Day 1 and Cycle 3 Day 1; Repeat Dose Schedule 3: Cycle 1 Day 1, 2, 3, 4, 5 and 8, Cycle 2 Day 1 and Cycle 3 Day 1 ]
  23. Part 1 Dose Escalation: Objective response rate (ORR): percentage of patients who had a best response [ Time Frame: Within the first year: every 6 weeks, thereafter every 12 weeks to end of treatment (EOT) visit (approximately 84 days), documented disease progression, withdrawal of consent, loss to follow-up, death or termination of the study (whichever occurs first) ]
  24. Part 1 Dose Escalation: Progression-free survival (PFS): duration of time from date of first dose to date of disease progression (according to RECIST v1.1) or death due to any cause, whichever comes first) [ Time Frame: Within the first year: every 6 weeks (±7 days); thereafter: every 12 weeks (±7 days); or when clinically indicated (Approximately 1 year ) ]
  25. Part 1 Dose Escalation: Overall survival (OS): time from date of first dose to death due to any cause [ Time Frame: Every 12 weeks±14 days after the last dose, until up to 2 years, withdrawal of consent, loss to follow-up, death, or termination of the study, whichever occurs first ]
  26. Part 1 Dose Escalation: Duration of response (DOR): duration of time a patient is evaluated as either complete response (CR) or partial response (PR) as best response until the first date that the criteria for progression are met, or death. [ Time Frame: Day 1 through 30 days after last dose, estimated to be 5 months ]
  27. Part 1 Dose Escalation: Disease control rate (DCR): proportion of patients who had a best response rating of complete response (CR) or partial response (PR), or stable disease (SD), which was maintained ≥6 weeks from Day 1 of Cycle 1 [ Time Frame: Day 1 through 30 days after last dose, estimated to be 5 months ]
  28. Part 2 Dose Expansion: Progression-free survival (PFS) duration of time from date of first dose to date of disease progression (according to RECIST v1.1) or death due to any cause, whichever comes first) [ Time Frame: Day 1 through 30 days after last dose, estimated to be 5 months ]
  29. Part 2 Dose Expansion: Duration of response (DOR) duration of time a patient is evaluated as either CR or PR as best response until the first date that the criteria for progression are met, or death [ Time Frame: Day 1 through 30 days after last dose, estimated to be 5 months ]
  30. Part 2 Dose Expansion: Incidence of Treatment emergent adverse events (TEAE) [ Time Frame: Day 1 through 30 days after last dose, estimated to be 5 months ]
  31. Part 2 Dose Expansion: Severity of Treatment emergent adverse events (TEAE) according to the NCI-CTCAE, version 5.0 [ Time Frame: Day 1 through 30 days after last dose, estimated to be 5 months ]
  32. Part 2 Dose Expansion: Number of patients with changes in Vital Signs [ Time Frame: Screening (Day -28) through 30 days after last dose, estimated to be 5 months ]
  33. Part 2 Dose Expansion: Number of patients with changes in Physical Examination [ Time Frame: Screening (Day -28) through 30 days after last dose, estimated to be 5 months ]
  34. Number of patients with changes in single and triplicate 12-lead Electrocardiogram (ECG) [ Time Frame: Screening (Day -28) through 30 days after last dose, estimated to be 5 months ]
  35. Number of patients with changes in Laboratory Test - Serum chemistry [ Time Frame: Screening (Day -28) through 30 days after last dose, estimated to be 5 months ]
  36. Number of patients with changes in Laboratory Test - Hematology [ Time Frame: Screening (Day -28) through 30 days after last dose, estimated to be 5 months ]
  37. Number of patients with changes in Laboratory Test - Coagulation parameters [ Time Frame: Screening (Day -28) through 30 days after last dose, estimated to be 5 months ]
  38. Number of patients with changes in Laboratory Test - Urinalysis [ Time Frame: Screening (Day -28) through 30 days after last dose, estimated to be 5 months ]


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

Key Inclusion Criteria:

  1. The patient must voluntarily participate in this clinical study. Be willing and able to provide written informed consent form (ICF) prior to any study activity.
  2. Age ≥18 years on the day of signing the ICF (either from screening period for dose escalation stage or from pre-screening period for dose expansion stage), males or females.
  3. The enrolled patients must have histologically or cytologically confirmed advanced solid tumor that is refractory to standard treatment or for which no standard treatment exists. The patients with known microsatellite-instability high (MSI- H) or deficient in mismatch repair (dMMR) disease are required to have received prior PD 1/PD-L1 therapy; those with known NTRK fusion are required to have received an approved TRK-inhibitor. The patients who are suitable for resection or other localized therapy that is potentially curative are not eligible.

Key Exclusion Criteria:

  1. Patients with active or untreated known CNS metastases and/or carcinomatous meningitis should be excluded.
  2. Patients with serious acute or chronic infections.
  3. Patients who have received prescription or non-prescription drugs or other products known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued 7 days prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of IMP7068.
  4. Patients who are participating in or have participated in a study of an investigational agent and received study therapy or used an investigational device within 28 days of the first dose of treatment.
  5. Patients have not recovered (i.e., to Grade ≤1 or to baseline, as evaluated by NCI-CTCAE Version 5.0) from prior anti-cancer therapy-induced AEs, except for alopecia.
  6. Patients who have undergone a major surgery or have undergone a radical radiotherapy within 28 days prior to the study treatment, or have undergone a palliative radiotherapy within 14 days prior to the study treatment, or have used a radioactive drug (Strontium, Samarium, etc.) within 56 days prior to the study treatment.
  7. Patients who are unable to swallow oral medications. Patients have gastrointestinal illnesses that may clinically significantly affect the absorption of oral medication IMP7068 at discretion of investigators.

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): NCT04768868


Contacts
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Contact: Bitao Sarapa 908-303-2808 bitao.sarapa@impacttherapeutics.com

Locations
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United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40202
Contact: Ben Orem    502-629-2500 ext 19471    Ben.Orem@nortonhealthcare.org   
Contact: Pamela Adkisson    502-629-2500 ext 19460    Pamela.Adkisson@nortonhealthcare.org   
Principal Investigator: Jaspreet Grewal, MD         
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Khin Win    702-952-3400    khin.win@usoncology.com   
Principal Investigator: Fadi Braiteh, MD         
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75230
Contact: James Strauss, MD    972-566-3000    Referral@MaryCrowley.Org   
Principal Investigator: James Strauss, MD         
Next Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Cynthia De Leon    210-580-9500    cdeleon@nextoncology.com   
Principal Investigator: Anthony Tolcher, MD         
China
Beijing Cancer Hospital Recruiting
Beijing, China, 100142
Contact: Haoyu Yang    13522171335    haoyu.yang@rg-pharma.com   
Principal Investigator: Lin Shen, MD         
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Contact: Pei-Chen Hsu    886-4-22052121 ext 5051    peggyshiu0807@gmail.com   
Principal Investigator: Li-Yuan Bai, MD         
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Contact: Yi-Zeng Wang    886-6-2353535 ext 3974    yizeng95020@gmail.com   
Principal Investigator: Yu-Min Yeh, MD         
Chi Mei Hospital, Liouying Recruiting
Tainan, Taiwan, 73657
Contact: Olivia Chen    886-6-6226999 ext 77649    hospital77649@gmail.com   
Principal Investigator: Yen-Hsun Chen, MD         
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Ying-Jan Chen    886-2-23123456 ext 68057    yingjanchen@ntuh.gov.tw   
Principal Investigator: Chia-Chi Lin, MD         
Sponsors and Collaborators
Impact Therapeutics, Inc.
Covance
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Responsible Party: Impact Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04768868    
Other Study ID Numbers: IMP7068 - 101
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Impact Therapeutics, Inc.:
Breast Cancer
Ovarian Cancer
Prostate Cancer
Pancreatic Cancers
Additional relevant MeSH terms:
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Neoplasms