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

Study Identifier:
CPG-02-101
CT.gov Identifier:
NCT04354246
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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Study Summary

To evaluate the safety, tolerability and preliminary antitumor activity of COM902 as monotherapy and in combination with COM701 in subjects with advanced malignancies. Antitumor activity was evaluated per RECIST v1.1 with CT imaging every 6 weeks starting from the first dose during the first 6 cycles of the study and every 12 weeks thereafter (or at any time point progressive disease is suspected) Safety assessment evaluated per CTCAE v5.0 Study builds on clinical benefit reported in heavily pretreated MSS CRC patients with liver metastases treated with dual combination of COM701 and nivolumab To evaluate the combination of COM701 with COM902 and pembrolizumab in up to 20 patients with metastatic microsatellite stable colorectal cancer patients who have previously received up to 3 lines of therapy. We present encouraging preliminary results. We enrolled 20 pts with metastatic MSS-CRC who all received COM701 15 mg/kg + COM902 3 mg/kg + pembrolizumab 200 mg all IV Q3W.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Unspecified Cancer
  • Ovarian
  • Other Lung Cancer
  • Bowel (Colorectal)
  • Plasma Cell Disorders
  • Multiple Myeloma
  • Head & Neck
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Arm Intervention/treatment
    • Read More
  • Drug: Experimental: Dual combination (COM902 + COM701) for evaluation of safety/tolerability (both at RDFE).
  • Drug: Experimental: COM902 monotherapy cohort expansion at RDFE.
  • Drug: Experimental: COM902 + COM701 combination cohort expansion both at RDFE.
  • Drug: Experimental: MSS-CRC Triplet combination (COM902 + COM701 + Pembrolizumab).
  • Drug: Experimental: Platinum resistant ovarian cancer Triplet combination (COM902 + COM701 + Pembrolizumab).
  • Drug: SITC 2021:
  • Drug: ASCO 2024:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • Age ≥ 18 yrs, measurable disease, MSS by IHC or genomic testing, ≤3 prior lines including fluroropyrimidines, irinotecan, and oxaliplatin.
    • 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.
    Exclusion criteria
    • prior receipt of ICI including anti-PVRIG, anti-TIGIT. Investigator assessed responses were per RECIST v1.1, safety per CTCAE v5.0.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Unspecified Cancer
    Ovarian
    Other Lung Cancer
    Bowel (Colorectal)
    Plasma Cell Disorders
    Multiple Myeloma
    Head & Neck
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Drew Rasco
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Unspecified Cancer
    Ovarian
    Other Lung Cancer
    Bowel (Colorectal)
    Plasma Cell Disorders
    Multiple Myeloma
    Head & Neck