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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 : August 4, 2021
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 August 4, 2021
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: July 29, 2021)
  • The safety and tolerability of COM902 monotherapy and in combination with COM701. [ 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 dose for expansion of COM902 monotherapy and in combination with COM701. [ Time Frame: 18 months. ]
    Evaluation of a dose of COM902 monotherapy and in combination with COM701 that is well tolerated by subjects.
  • To characterize the pharmacokinetic (PK) profile of COM902 as monotherapy and in combination with COM701. [ Time Frame: 18 months. ]
    Evaluation of parameters of COM902 monotherapy or in combination with COM701 exposure such as Maximum Plasma Concentration [Cmax]).
Original 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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2021)
To characterize immunogenicity of COM902 monotherapy and in combination with COM701. [ Time Frame: 18 months. ]
Evaluation of anti drug antibody to COM902 (monotherapy) or COM902, COM701 when administered in combination.
Original 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.
Current Other Pre-specified Outcome Measures
 (submitted: July 29, 2021)
Evaluation of the preliminary antitumor activity of COM902 as monotherapy and in combination with COM701. [ Time Frame: 24 months. ]
An assessment of preliminary antitumor activity eg ORR with COM902 monotherapy and COM902 in combination with COM701.
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 antitumor activity of COM902 as monotherapy and in combination with COM701 in subjects with advanced malignancies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Cancer
  • Ovarian Cancer
  • Lung Cancer
  • Colon Cancer
  • Plasma Cell Neoplasm
  • Multiple Myeloma
  • HNSCC
Intervention  ICMJE
  • Drug: Dose escalation: COM902 monotherapy.
    COM902 monotherapy administered IV every 3 weeks in sequential dose escalation doses in cohorts of subjects.
  • Combination Product: Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE)
    Both study drugs will be evaluated at the RDFE for assessment of safety and tolerability. All study drugs will be administered IV every 3 weeks.
  • Drug: Cohort expansion: COM902 (RDFE) monotherapy.
    COM902 monotherapy (RDFE) in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.
  • Drug: Cohort expansion: COM902 in combination with COM701 (both at the RDFE).
    COM902 in combination with COM701 (both at RDFE) in subjects with select tumor types who have exhausted standard treatment - HNSCC, CRC (MSS), NSCLC. All study drugs will be administered IV every 3 weeks.
Study Arms  ICMJE
  • Experimental: COM902 monotherapy dose escalation.
    Monotherapy dose escalation. COM902 monotherapy administered IV every 3 weeks in sequential dose escalation. Up to 7 dose escalation cohorts may be evaluated until a maximum tolerated dose or recommended dose for expansion (RDFE) is identified.
    Intervention: Drug: Dose escalation: COM902 monotherapy.
  • Experimental: Dual combination (COM902 + COM701) for evaluation of safety/tolerability (both at RDFE).
    COM902 will be combined with COM701 for evaluation of safety and tolerability. All study drugs will be administered IV every 3 weeks.
    Intervention: Combination Product: Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE)
  • Experimental: COM902 monotherapy cohort expansion at RDFE.
    COM902 monotherapy at the RDFE - in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.
    Intervention: Drug: Cohort expansion: COM902 (RDFE) monotherapy.
  • Experimental: COM902 + COM701 combination cohort expansion both at RDFE.
    COM902 + COM701 (both at the RDFE) evaluated in subjects with select tumor types who have exhausted standard of care treatment: HNSCC, CRC (MSS), NSCLC. All study drugs will be administered IV every 3 weeks.
    Intervention: Drug: Cohort expansion: COM902 in combination with COM701 (both at the RDFE).
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: July 29, 2021)
90
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2020)
45
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 July 2021

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