CompletedPhase 1NCT03667716

COM701 (an Inhibitor of PVRIG) 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.

Checked against the public recordLast updated Jan 17, 2025 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations11
SponsorCompugen Ltd
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Compugen Ltd
Interventions being studied
Drug: COM701; Drug: COM701 with Opdivo (Nivolumab).
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • University of California Los Angeles (UCLA).Los Angeles, California
  • Florida Cancer SpecialistsSarasota, Florida
  • University of Chicago Medical CenterChicago, Illinois
  • Massachusetts General HospitalBoston, Massachusetts
  • START Midwest.Grand Rapids, Michigan
  • Columbia UniversityNew York, New York
  • Cleveland Clinic.Cleveland, Ohio
  • The University of Tennessee WEST Cancer Center.Memphis, Tennessee
  • Sarah Cannon Research Institute.Nashville, Tennessee
  • M D Anderson Cancer Center.Houston, Texas
  • The START Center for Cancer Care.San Antonio, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 17, 2025. Always confirm current availability with the study team.

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