Clinical Trials /

COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies

NCT04354246

Description:

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.

Related Conditions:
  • Colorectal Carcinoma
  • Malignant Solid Tumor
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04354246

Trial Eligibility

Document

Title

  • Brief Title: COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies
  • Official Title: A Phase 1 Study of The Safety and Tolerability of COM902 in Subjects With Advanced Malignancies

Clinical Trial IDs

  • ORG STUDY ID: CPG-02-101
  • NCT ID: NCT04354246

Conditions

  • Advanced Cancer
  • Ovarian Cancer
  • Lung Cancer
  • Colon Cancer
  • Plasma Cell Neoplasm
  • Multiple Myeloma
  • HNSCC

Interventions

DrugSynonymsArms
Dose escalation: COM902 monotherapy.COM902 monotherapy dose escalation.
Cohort expansion: COM902 (RDFE) monotherapy.COM902 monotherapy cohort expansion at RDFE.
Cohort expansion: COM902 in combination with COM701 (both at the RDFE).COM902 + COM701 combination cohort expansion both at RDFE.

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
COM902 monotherapy dose escalation.ExperimentalMonotherapy 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.
  • Dose escalation: COM902 monotherapy.
Dual combination (COM902 + COM701) for evaluation of safety/tolerability (both at RDFE).ExperimentalCOM902 will be combined with COM701 for evaluation of safety and tolerability. All study drugs will be administered IV every 3 weeks.
    COM902 monotherapy cohort expansion at RDFE.ExperimentalCOM902 monotherapy at the RDFE - in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.
    • Cohort expansion: COM902 (RDFE) monotherapy.
    COM902 + COM701 combination cohort expansion both at RDFE.ExperimentalCOM902 + 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.
    • Cohort expansion: COM902 in combination with COM701 (both at the RDFE).

    Eligibility Criteria

            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.
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:The safety and tolerability of COM902 monotherapy and in combination with COM701.
    Time Frame:DLT evaluation window in the 1st cycle (21 Days).
    Safety Issue:
    Description:Incidence of subjects with Adverse Events (AEs) as per CTCAE v5.0 and Dose-Limiting Toxicities (DLTs).

    Secondary Outcome Measures

    Measure:To characterize immunogenicity of COM902 monotherapy and in combination with COM701.
    Time Frame:18 months.
    Safety Issue:
    Description:Evaluation of anti drug antibody to COM902 (monotherapy) or COM902, COM701 when administered in combination.

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Compugen Ltd

    Last Updated

    August 4, 2021