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COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04354246
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Compugen Ltd

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Ovarian Cancer Lung Cancer Colon Cancer Plasma Cell Neoplasm Breast Cancer Drug: COM902 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of The Safety and Tolerability of COM902 in Subjects With Advanced Malignancies
Actual Study Start Date : March 31, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2022


Arm Intervention/treatment
Experimental: COM902 Monotherapy Dose Escalation Arm.
Monotherapy 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.
Drug: COM902
COM902 monotherapy administered IV Q3 weeks in sequential dose escalation doses in cohorts of subjects.




Primary Outcome Measures :
  1. The safety and tolerability of COM902 monotherapy. [ Time Frame: DLT evaluation window in the 1st cycle (21 Days). ]
    Incidence of subjects with Adverse Events (AEs) as per CTCAE v5.0 and Dose-Limiting Toxicities (DLTs).

  2. To identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). [ Time Frame: 18 months. ]
    Evaluation of preliminary antitumor activity of COM902.

  3. To characterize the pharmacokinetic (PK) profile of COM902 as monotherapy in subjects with advanced malignancies. [ Time Frame: 18 months. ]
    Evaluation of parameters of COM902 exposure such as Maximum Plasma Concentration [Cmax]) of COM902.

  4. To characterize the pharmacokinetic (PK) profile of COM902 as monotherapy in subjects with advanced malignancies. [ Time Frame: 18 months. ]
    Evaluation of parameters of COM902 exposure such as Area under the curve (AUC).


Secondary Outcome Measures :
  1. To characterize immunogenicity of COM902 monotherapy [ Time Frame: 18 months. ]
    Evaluation of anti drug antibody to COM902.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04354246


Contacts
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Contact: Lead COM902 ClinInfo ‪+1 415 373 0781 COM902-001@cgen.com
Contact: Backup COM902 ClinInfo +1 415 373 0781 COM902-001@cgen.com

Locations
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United States, Michigan
START Midwest. Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: COM902 Study Director    415-373-0781    COM902-001@cgen.com   
Sponsors and Collaborators
Compugen Ltd
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Responsible Party: Compugen Ltd
ClinicalTrials.gov Identifier: NCT04354246    
Other Study ID Numbers: CPG-02-101
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Plasma Cell
Multiple Myeloma
Plasmacytoma
Neoplasms
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases