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 clinical activity of COM902 as monotherapy in subjects with advanced malignancies.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

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
  • Breast Cancer

Interventions

DrugSynonymsArms
COM902COM902 Monotherapy Dose Escalation Arm.

Purpose

Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary clinical activity of COM902 as monotherapy in subjects with advanced malignancies.

Trial Arms

NameTypeDescriptionInterventions
COM902 Monotherapy Dose Escalation Arm.ExperimentalMonotherapy Dose Escalation. COM902 monotherapy administered IV every 3 weeks in sequential dose escalation Cohorts using a rules-based design. Up to 7 dose escalation cohorts may be evaluated until a maximum tolerated dose or recommended phase 2 dose is identified.
  • COM902

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.
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
Time Frame:18 months.
Safety Issue:
Description:Evaluation of anti drug antibody to COM902.

Details

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

Last Updated

April 16, 2020