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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 : March 24, 2023
Sponsor:
Information provided by (Responsible Party):
Compugen Ltd

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Ovarian Cancer Lung Cancer Colon Cancer Plasma Cell Neoplasm Multiple Myeloma HNSCC Microsatellite Stable Colorectal Carcinoma MSS-CRC Drug: Dose escalation: COM902 monotherapy. Combination Product: Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE) Drug: Cohort expansion: COM902 (RDFE) monotherapy. Drug: Cohort expansion: COM902 in combination with COM701 (both at the RDFE). Combination Product: Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab. Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Non-Randomized
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 : December 30, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: COM902 monotherapy dose escalation.
Monotherapy 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.
 Drug: Dose escalation: COM902 monotherapy.
COM902 monotherapy administered IV every 3 weeks in sequential dose escalation doses in cohorts of subjects.
Experimental: Dual combination (COM902 + COM701) for evaluation of safety/tolerability (both at RDFE).
COM902 will be combined with COM701 for evaluation of safety and tolerability. All study drugs will be administered IV every 3 weeks.
 Combination Product: Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE)
Both study drugs will be evaluated at the RDFE for assessment of safety and tolerability. All study drugs will be administered IV every 3 weeks.
Experimental: COM902 monotherapy cohort expansion at RDFE.
COM902 monotherapy at the RDFE - in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.
 Drug: Cohort expansion: COM902 (RDFE) monotherapy.
COM902 monotherapy (RDFE) in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.
Experimental: COM902 + COM701 combination cohort expansion both at RDFE.
COM902 + 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.
 Drug: Cohort expansion: COM902 in combination with COM701 (both at the RDFE).
COM902 in combination with COM701 (both at RDFE) in subjects with select tumor types who have exhausted standard treatment - HNSCC, CRC (MSS), NSCLC. All study drugs will be administered IV every 3 weeks.
Experimental: MSS-CRC Triplet combination (COM902 + COM701 + Pembrolizumab).
Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with MSS-CRC. All study drugs will be administered IV every 3 weeks.
 Combination Product: Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.
Triplet combination of COM902 + COM701 + Pembrolizumab administered IV every 3 weeks.
Experimental: Platinum resistant ovarian cancer Triplet combination (COM902 + COM701 + Pembrolizumab).
Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with PROC. All study drugs will be administered IV every 3 weeks.
 Combination Product: Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.
Triplet combination of COM902 + COM701 + Pembrolizumab administered IV every 3 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. The safety and tolerability of COM902 monotherapy and in combination with COM701. [ 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 dose for expansion of COM902 monotherapy and in combination with COM701. [ Time Frame: 18 months. ]
    Evaluation of a dose of COM902 monotherapy and in combination with COM701 that is well tolerated by subjects.

  3. To characterize the pharmacokinetic (PK) profile of COM902 as monotherapy and in combination with COM701. [ Time Frame: 18 months. ]
    Evaluation of parameters of COM902 monotherapy or in combination with COM701 exposure such as Maximum Plasma Concentration [Cmax]).

  4. Evaluation of safety and tolerability of the Triplet combination (COM902 + COM701 + Pembrolizumab). [ Time Frame: 18 months. ]
    Incidence of subjects on the Triplet combination (COM902 + COM701 + Pembrolizumab) with Adverse Events (AEs) per CTCAE v5.0.

  5. Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab). [ Time Frame: 18 months. ]
    Evaluation of PK parameters e.g., Cmax.

  6. Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab). [ Time Frame: 18 months. ]
    Evaluation of PK parameters e.g., AUC.


Secondary Outcome Measures :
  1. To characterize immunogenicity of COM902 monotherapy and in combination with COM701. [ Time Frame: 18 months. ]
    Evaluation of anti drug antibody to COM902 (monotherapy) or COM902, COM701 when administered in combination.

  2. To characterize the immunogenicity of the Triplet combination (COM902 + COM701 + Pembrolizumab). [ Time Frame: 18 months. ]
    Evaluation of antidrug antibody to COM902, COM701.


Other Outcome Measures:
  1. Evaluation of the preliminary antitumor activity of COM902 as monotherapy and in combination with COM701. [ Time Frame: 24 months. ]
    An assessment of preliminary antitumor activity eg ORR with COM902 monotherapy and COM902 in combination with COM701.

  2. Preliminary antitumor activity of the triplet combination (COM902 + COM701 + Pembrolizumab). [ Time Frame: 24 months ]
    Assessment of preliminary antitumor activity e.g., ORR.


Eligibility Criteria
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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.

For Triplet combination MSS-CRC:

  • Histologically confirmed adenocarcinoma of the colon/rectum
  • Stage IV disease
  • MSS-CRC status by an FDA approved test
  • Disease progression with no more than 3 prior lines of treatment including fluroropyrimidines, irinotecan, and oxaliplatin

For Triplet combination ovarian cancer:

  • Advanced epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
  • Platinum resistant ovarian cancer (PROC) defined as disease recurrence < 6 months after completion of a platinum-containing regimen: Patients with primary platinum refractory disease are ineligible. Primary platinum refractory disease is defined as progression of disease prior to completion of 1st line platinum therapy or immediately following (≤ 3 months following last date of chemotherapy)
  • Received ≤3 prior lines for PROC; maintenance bevacizumab or PARP are not included as a line of therapy
  • Subjects who have received PARP inhibitor therapy are eligible

Key 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.

Contacts and Locations
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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   
United States, Ohio
The Ohio State University Comprehensive Cancer Center. Recruiting
Columbus, Ohio, United States, 43210
Contact: COM902 Study Director    415-373-0781    COM902-001@cgen.com   
United States, Tennessee
The University of Tennessee WEST Cancer Center. Recruiting
Memphis, Tennessee, United States, 38138
Contact: COM902 Study Director.    415-373-0781    COM902-001@cgen.com   
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75230
Contact: COM902 Study Director.    415-373-0781    COM902-001@cgen.com   
MD Anderson Cancer Center. Recruiting
Houston, Texas, United States, 77030
Contact: COM902 Study Director    415-373-0781    COM902-001@cgen.com   
The START Center for Cancer Care. Recruiting
San Antonio, Texas, United States, 78229
Contact: COM902 Study Director    415-373-0781    COM902-001@cgen.com   
United States, Wisconsin
Froedtert & Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: COM902 Study Director    415-373-0781    COM902-001@cgen.com   
Sponsors and Collaborators
Compugen Ltd
More Information
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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: March 24, 2023
Last Verified: March 2023
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
Keywords provided by Compugen Ltd:
TIGIT antibody
PVRIG antibody
COM701
Low Fc-effector function
Pembrolizumab
Additional relevant MeSH terms:
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Multiple Myeloma
Colorectal Neoplasms
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
 Immune System Diseases
Neoplasms by Site
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action