COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies

February 10, 2024 updated by: Compugen Ltd

A Phase 1 Study of The Safety and Tolerability of COM902 in Subjects With Advanced Malignancies

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34230
        • Recruiting
        • Florida Cancer Specialists
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital.
        • Contact:
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • START Midwest.
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Comprehensive Cancer Center.
        • Contact:
    • Tennessee
      • Memphis, Tennessee, United States, 38138
        • Recruiting
        • The University of Tennessee WEST Cancer Center.
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Mary Crowley Cancer Research
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center.
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • The START Center for Cancer Care.
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert & Medical College of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

For Triplet combination MSS-CRC:

  • Histologically confirmed adenocarcinoma of the colon/rectum
  • Stage IV disease
  • MSS-CRC status by an FDA approved test
  • Disease progression with no more than 3 prior lines of treatment including fluroropyrimidines, irinotecan, and oxaliplatin

For Triplet combination ovarian cancer:

  • Advanced epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
  • Platinum resistant ovarian cancer (PROC) defined as disease recurrence < 6 months after completion of a platinum-containing regimen: Patients with primary platinum refractory disease are ineligible. Primary platinum refractory disease is defined as progression of disease prior to completion of 1st line platinum therapy or immediately following (≤ 3 months following last date of chemotherapy)
  • Received ≤3 prior lines for PROC; maintenance bevacizumab or PARP are not included as a line of therapy
  • Subjects who have received PARP inhibitor therapy are eligible

Key Exclusion Criteria:

  • Prior treatment with a TIGIT inhibitor.
  • Prior treatment with an inhibitor of PVRIG
  • Symptomatic interstitial lung disease or inflammatory pneumonitis.
  • History of immune-related events that required immunotherapy treatment discontinuation

For Triplet combination expansion cohorts (MSS-CRC and PROC): Prior treatment with an anti-PD-1/PD-L1/2, anti-CD96 antibody, anti-OX-40 antibody, anti-CD137 antibody, anti-LAG3, anti-TIM3, anti-CTLA4 antibody.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Dose escalation: COM902 monotherapy.
COM902 monotherapy administered IV every 3 weeks in sequential dose escalation doses in cohorts of subjects.
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.
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.
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.
Drug: Cohort expansion: COM902 (RDFE) monotherapy.
COM902 monotherapy (RDFE) in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.
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.
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.
Experimental: MSS-CRC Triplet combination (COM902 + COM701 + Pembrolizumab).
Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with MSS-CRC. All study drugs will be administered IV every 3 weeks.
Combination product: Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.
Triplet combination of COM902 + COM701 + Pembrolizumab administered IV every 3 weeks.
Experimental: Platinum resistant ovarian cancer Triplet combination (COM902 + COM701 + Pembrolizumab).
Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with PROC. All study drugs will be administered IV every 3 weeks.
Combination product: Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.
Triplet combination of COM902 + COM701 + Pembrolizumab administered IV every 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
DLT evaluation window in the 1st cycle (21 Days).
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.
18 months.
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]).
18 months.
Evaluation of safety and tolerability of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Time Frame: 18 months.
Incidence of subjects on the Triplet combination (COM902 + COM701 + Pembrolizumab) with Adverse Events (AEs) per CTCAE v5.0.
18 months.
Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Time Frame: 18 months.
Evaluation of PK parameters e.g., Cmax.
18 months.
Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Time Frame: 18 months.
Evaluation of PK parameters e.g., AUC.
18 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months.
To characterize the immunogenicity of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Time Frame: 18 months.
Evaluation of antidrug antibody to COM902, COM701.
18 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months.
Preliminary antitumor activity of the triplet combination (COM902 + COM701 + Pembrolizumab).
Time Frame: 24 months
Assessment of preliminary antitumor activity e.g., ORR.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Compugen Ltd

Investigators

  • Study Director: COM902 Study Director COM902 Study Director, Compugen Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2020

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 16, 2020

First Posted (Actual)

April 21, 2020

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 10, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPG-02-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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