COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.

January 15, 2025 updated by: Compugen Ltd

A Phase 1a/1b Study of COM701 as Monotherapy and In Combination With an Anti-PD-1 Antibody in Subjects With Advanced Solid Tumors.

This is a Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary clinical activity of COM701 as monotherapy and in combination with nivolumab.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This Phase 1 study evaluates the safety, tolerability, Pharmacokinetics (PK) and preliminary clinical activity of COM701 an inhibitor of poliovirus receptor related immunoglobulin domain containing (PVRIG) as monotherapy and in combination with nivolumab in subjects with advanced solid tumors. Cohort expansion will be explored evaluating COM701 monotherapy and in combination with nivolumab in subjects with the following select tumor types (Non-Small cell lung cancer (NSCLC), Ovarian, Breast (including Triple negative breast cancer (TNBC) and endometrial cancer. Other tumor types such as CRC-MSS, CRC-KRAS mutant will be enrolled based on emerging clinical activity data.

Study Type

Interventional

Enrollment (Actual)

121

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 Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles (UCLA).
    • Florida
      • Sarasota, Florida, United States, 34230
        • Florida Cancer Specialists
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • START Midwest.
    • New York
      • New York, New York, United States, 10032
        • Columbia University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic.
    • Tennessee
      • Memphis, Tennessee, United States, 38138
        • The University of Tennessee WEST Cancer Center.
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute.
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center.
      • San Antonio, Texas, United States, 78229
        • The START Center for Cancer Care.

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:

  • Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Subjects who received prior immune-stimulatory antitumor agents, such as anti-PD-1, anti-PD-L1, anti-CTLA-4, OX-40, CD137, etc. are eligible.
  • Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy and has exhausted all the available standard therapy or is not a candidate for the available standard therapy.

Select Tumor Types (COM701 monotherapy cohort expansion; COM701 in combination with nivolumab):

  • Breast cancer (TNBC): Histologically confirmed incurable, advanced estrogen receptor-, progesterone receptor-, and human epidermal growth factor receptor 2 (HER2)-negative (triple-negative) adenocarcinoma of the breast, as defined by the American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) guidelines. Disease recurrence or progression during or after at least one systemic treatment that included an anthracycline and/or a taxane in the neoadjuvant, adjuvant, or metastatic setting. Subjects must have progressed after a poly ADP-ribose polymerase (PARP) inhibitor for patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA) mutated metastatic breast cancer. P1b COM701 + nivolumab expansion cohort, COM701 monotherapy expansion cohort.
  • Endometrial cancer: Subjects with locally advanced or metastatic endometrial cancer, disease recurrence or progression during or after prior therapy that included platinum-based chemotherapy. P1b COM701 + nivolumab expansion cohort, COM701 monotherapy expansion cohort.
  • Ovarian cancer: Disease recurrence or progression during or after prior therapy that included: surgical resection, platinum agent, PARP inhibitor (for subjects with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer or as a maintenance therapy for subjects who have had complete or partial response to platinum-based therapy). P1b COM701 + nivolumab expansion cohort, COM701 monotherapy expansion cohort.
  • NSCLC: Documented stage IIIB or IV or recurrent NSCLC, Disease recurrence or progression during or after prior treatment that included: platinum agent, targeted therapy such as a TKI (if with biopsy-confirmed cytogenetic mutation eg EGFR, ROS, BRAF). COM701 monotherapy expansion cohort.
  • CRC (microsatellite stable, KRAS mutation) - P1b COM701 + nivolumab expansion cohort, COM701 monotherapy expansion cohort.
  • For Phase 1a monotherapy expansion and Phase 1b only: subject has at least one measurable lesion that could be followed during the study according to RECIST v1.1.

Key Exclusion Criteria:

  • Active autoimmune disease requiring systemic therapy in the last 2 years prior to the first dose of COM701.
  • Symptomatic interstitial lung disease or inflammatory pneumonitis.
  • History of immune-related events that lead to immunotherapy treatment discontinuation.
  • Untreated or symptomatic central nervous system (CNS) metastases.
  • Impaired cardiac function or clinically significant cardiac disease, including any of the following: a) Unstable angina pectoris ≤ 6 months prior to first scheduled dose of COM701; b) Acute myocardial infarction ≤ 6 months prior to first scheduled dose of COM701.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: P1a Arm A (Monotherapy Dose Escalation).
COM701 monotherapy sequential dose escalation administered IV every 3 weeks and a Cohort IV every 4 weeks. Up to 8 dose escalation cohorts may be evaluated until a maximum tolerated dose or recommended phase 2 dose is identified.
Drug: COM701
COM701 monotherapy.
Experimental: P1a Arm B (Combination Dose Escalation).
COM701 sequential dose escalation administered IV every 3 weeks in combination with Opdivo (Nivolumab) 360mg administered IV every 3 weeks and COM701 administered IV every 4 weeks in combination with Opdivo (Nivolumab) 480mg administered IV every 4 weeks.
Drug: COM701 with Opdivo (Nivolumab).
COM701 in combination with Opdivo (Nivolumab).
Experimental: P1a Arm A (Monotherapy Expansion).
COM701 monotherapy administered IV every 4 weeks. Cohort expansion in subjects with the following select tumor types (NSCLC, Breast, Ovarian, Endometrial and Colorectal cancer).
Drug: COM701
COM701 monotherapy.
Experimental: P1b (Combination Cohort Dose Expansion).
COM701 administered IV every 4 weeks in combination with Opdivo (Nivolumab) 480 mg administered IV every 4 weeks. Cohort expansion in subjects with the following select tumor types (Breast, Ovarian, Endometrial and Colorectal cancer).
Drug: COM701 with Opdivo (Nivolumab).
COM701 in combination with Opdivo (Nivolumab).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of subjects with Adverse Events (AEs) as per CTCAE v4.03 and Dose-Limiting Toxicities (DLTs).
Time Frame: DLT evaluation window in the 1st cycle (21 or 28 days).
To evaluate the safety profile of COM701 monotherapy and in combination with nivolumab.
DLT evaluation window in the 1st cycle (21 or 28 days).
Determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDFE) (COM701 monotherapy and in combination with nivolumab).
Time Frame: Approximately 2 year.
Approximately 2 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of subjects with Anti-COM701 antibody.
Time Frame: Approximately 2 years.
Immunogenicity of COM701 monotherapy and in combination with nivolumab.
Approximately 2 years.
Overall Response Rate as per RECIST v1.1
Time Frame: Approximately 2 years.
Preliminary antitumor activity of COM701 in combination with nivolumab.
Approximately 2 years.

Collaborators and Investigators

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

Sponsor

Compugen Ltd

Collaborators

Bristol-Myers Squibb

Investigators

  • Study Director: COM701 Study Director, Compugen USA, Inc.

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)

September 6, 2018

Primary Completion (Actual)

January 30, 2024

Study Completion (Actual)

January 30, 2024

Study Registration Dates

First Submitted

September 10, 2018

First Submitted That Met QC Criteria

September 11, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPG-01-001

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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