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Trial record 1 of 1 for:    CPG-02-101
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COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies

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ClinicalTrials.gov Identifier: NCT04354246
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
Compugen Ltd

Tracking Information
First Submitted Date  ICMJE April 15, 2020
First Posted Date  ICMJE April 21, 2020
Last Update Posted Date December 21, 2020
Actual Study Start Date  ICMJE March 31, 2020
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2020)
  • The safety and tolerability of COM902 monotherapy. [ Time Frame: DLT evaluation window in the 1st cycle (21 Days). ]
    Incidence of subjects with Adverse Events (AEs) as per CTCAE v5.0 and Dose-Limiting Toxicities (DLTs).
  • To identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). [ Time Frame: 18 months. ]
    Evaluation of preliminary antitumor activity of COM902.
  • To characterize the pharmacokinetic (PK) profile of COM902 as monotherapy in subjects with advanced malignancies. [ Time Frame: 18 months. ]
    Evaluation of parameters of COM902 exposure such as Maximum Plasma Concentration [Cmax]) of COM902.
  • To characterize the pharmacokinetic (PK) profile of COM902 as monotherapy in subjects with advanced malignancies. [ Time Frame: 18 months. ]
    Evaluation of parameters of COM902 exposure such as Area under the curve (AUC).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2020)
To characterize immunogenicity of COM902 monotherapy [ Time Frame: 18 months. ]
Evaluation of anti drug antibody to COM902.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies
Official Title  ICMJE A Phase 1 Study of The Safety and Tolerability of COM902 in Subjects With Advanced Malignancies
Brief Summary Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary clinical activity of COM902 as monotherapy in subjects with advanced malignancies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Cancer
  • Ovarian Cancer
  • Lung Cancer
  • Colon Cancer
  • Plasma Cell Neoplasm
  • Breast Cancer
Intervention  ICMJE Drug: COM902
COM902 monotherapy administered IV Q3 weeks in sequential dose escalation doses in cohorts of subjects.
Study Arms  ICMJE Experimental: COM902 Monotherapy Dose Escalation Arm.
Monotherapy Dose Escalation. COM902 monotherapy administered IV every 3 weeks in sequential dose escalation Cohorts using a rules-based design. Up to 7 dose escalation cohorts may be evaluated until a maximum tolerated dose or recommended phase 2 dose is identified.
Intervention: Drug: COM902
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2020)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Subjects with histologically/cytologically confirmed advanced malignancy (solid tumor) who must have exhausted all available standard therapy; or not a candidate for standard therapy.
  • Subject is able to provide written, informed consent before initiation of any study related procedures, and is able, in the opinion of the investigator, to comply with all the requirements of the study.
  • Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Key Exclusion Criteria:

  • Prior treatment with a TIGIT inhibitor.
  • Symptomatic interstitial lung disease or inflammatory pneumonitis.
  • History of immune-related events that required immunotherapy treatment discontinuation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lead COM902 ClinInfo ‪+1 415 373 0781 COM902-001@cgen.com
Contact: Backup COM902 ClinInfo +1 415 373 0781 COM902-001@cgen.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04354246
Other Study ID Numbers  ICMJE CPG-02-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Compugen Ltd
Study Sponsor  ICMJE Compugen Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Compugen Ltd
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP