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COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies

Primary Purpose

Advanced Cancer, Ovarian Cancer, Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dose escalation: COM902 monotherapy.
Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE)
Cohort expansion: COM902 (RDFE) monotherapy.
Cohort expansion: COM902 in combination with COM701 (both at the RDFE).
Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.
Sponsored by
Compugen Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cancer focused on measuring TIGIT antibody, PVRIG antibody, COM701, Low Fc-effector function, Pembrolizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Florida Cancer SpecialistsRecruiting
  • Massachusetts General Hospital.Recruiting
  • START Midwest.Recruiting
  • The Ohio State University Comprehensive Cancer Center.Recruiting
  • The University of Tennessee WEST Cancer Center.Recruiting
  • Mary Crowley Cancer ResearchRecruiting
  • MD Anderson Cancer Center.Recruiting
  • The START Center for Cancer Care.Recruiting
  • Froedtert & Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

COM902 monotherapy dose escalation.

Dual combination (COM902 + COM701) for evaluation of safety/tolerability (both at RDFE).

COM902 monotherapy cohort expansion at RDFE.

COM902 + COM701 combination cohort expansion both at RDFE.

MSS-CRC Triplet combination (COM902 + COM701 + Pembrolizumab).

Platinum resistant ovarian cancer Triplet combination (COM902 + COM701 + Pembrolizumab).

Arm Description

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.

COM902 will be combined with COM701 for evaluation of safety and tolerability. All study drugs will be administered IV every 3 weeks.

COM902 monotherapy at the RDFE - in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.

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.

Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with MSS-CRC. All study drugs will be administered IV every 3 weeks.

Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with PROC. All study drugs will be administered IV every 3 weeks.

Outcomes

Primary Outcome Measures

The safety and tolerability of COM902 monotherapy and in combination with COM701.
Incidence of subjects with Adverse Events (AEs) as per CTCAE v5.0 and Dose-Limiting Toxicities (DLTs).
To identify the maximum tolerated dose (MTD) and/or recommended dose for expansion of COM902 monotherapy and in combination with COM701.
Evaluation of a dose of COM902 monotherapy and in combination with COM701 that is well tolerated by subjects.
To characterize the pharmacokinetic (PK) profile of COM902 as monotherapy and in combination with COM701.
Evaluation of parameters of COM902 monotherapy or in combination with COM701 exposure such as Maximum Plasma Concentration [Cmax]).
Evaluation of safety and tolerability of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Incidence of subjects on the Triplet combination (COM902 + COM701 + Pembrolizumab) with Adverse Events (AEs) per CTCAE v5.0.
Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Evaluation of PK parameters e.g., Cmax.
Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Evaluation of PK parameters e.g., AUC.

Secondary Outcome Measures

To characterize immunogenicity of COM902 monotherapy and in combination with COM701.
Evaluation of anti drug antibody to COM902 (monotherapy) or COM902, COM701 when administered in combination.
To characterize the immunogenicity of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Evaluation of antidrug antibody to COM902, COM701.

Full Information

First Posted
April 15, 2020
Last Updated
August 11, 2023
Sponsor
Compugen Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04354246
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Compugen Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer, Ovarian Cancer, Lung Cancer, Colon Cancer, Plasma Cell Neoplasm, Multiple Myeloma, HNSCC, Microsatellite Stable Colorectal Carcinoma, MSS-CRC
Keywords
TIGIT antibody, PVRIG antibody, COM701, Low Fc-effector function, Pembrolizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COM902 monotherapy dose escalation.
Arm Type
Experimental
Arm Description
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.
Arm Title
Dual combination (COM902 + COM701) for evaluation of safety/tolerability (both at RDFE).
Arm Type
Experimental
Arm Description
COM902 will be combined with COM701 for evaluation of safety and tolerability. All study drugs will be administered IV every 3 weeks.
Arm Title
COM902 monotherapy cohort expansion at RDFE.
Arm Type
Experimental
Arm Description
COM902 monotherapy at the RDFE - in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.
Arm Title
COM902 + COM701 combination cohort expansion both at RDFE.
Arm Type
Experimental
Arm Description
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.
Arm Title
MSS-CRC Triplet combination (COM902 + COM701 + Pembrolizumab).
Arm Type
Experimental
Arm Description
Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with MSS-CRC. All study drugs will be administered IV every 3 weeks.
Arm Title
Platinum resistant ovarian cancer Triplet combination (COM902 + COM701 + Pembrolizumab).
Arm Type
Experimental
Arm Description
Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with PROC. All study drugs will be administered IV every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Dose escalation: COM902 monotherapy.
Intervention Description
COM902 monotherapy administered IV every 3 weeks in sequential dose escalation doses in cohorts of subjects.
Intervention Type
Combination Product
Intervention Name(s)
Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cohort expansion: COM902 (RDFE) monotherapy.
Intervention Description
COM902 monotherapy (RDFE) in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Cohort expansion: COM902 in combination with COM701 (both at the RDFE).
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.
Intervention Description
Triplet combination of COM902 + COM701 + Pembrolizumab administered IV every 3 weeks.
Primary Outcome Measure Information:
Title
The safety and tolerability of COM902 monotherapy and in combination with COM701.
Description
Incidence of subjects with Adverse Events (AEs) as per CTCAE v5.0 and Dose-Limiting Toxicities (DLTs).
Time Frame
DLT evaluation window in the 1st cycle (21 Days).
Title
To identify the maximum tolerated dose (MTD) and/or recommended dose for expansion of COM902 monotherapy and in combination with COM701.
Description
Evaluation of a dose of COM902 monotherapy and in combination with COM701 that is well tolerated by subjects.
Time Frame
18 months.
Title
To characterize the pharmacokinetic (PK) profile of COM902 as monotherapy and in combination with COM701.
Description
Evaluation of parameters of COM902 monotherapy or in combination with COM701 exposure such as Maximum Plasma Concentration [Cmax]).
Time Frame
18 months.
Title
Evaluation of safety and tolerability of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Description
Incidence of subjects on the Triplet combination (COM902 + COM701 + Pembrolizumab) with Adverse Events (AEs) per CTCAE v5.0.
Time Frame
18 months.
Title
Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Description
Evaluation of PK parameters e.g., Cmax.
Time Frame
18 months.
Title
Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Description
Evaluation of PK parameters e.g., AUC.
Time Frame
18 months.
Secondary Outcome Measure Information:
Title
To characterize immunogenicity of COM902 monotherapy and in combination with COM701.
Description
Evaluation of anti drug antibody to COM902 (monotherapy) or COM902, COM701 when administered in combination.
Time Frame
18 months.
Title
To characterize the immunogenicity of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Description
Evaluation of antidrug antibody to COM902, COM701.
Time Frame
18 months.
Other Pre-specified Outcome Measures:
Title
Evaluation of the preliminary antitumor activity of COM902 as monotherapy and in combination with COM701.
Description
An assessment of preliminary antitumor activity eg ORR with COM902 monotherapy and COM902 in combination with COM701.
Time Frame
24 months.
Title
Preliminary antitumor activity of the triplet combination (COM902 + COM701 + Pembrolizumab).
Description
Assessment of preliminary antitumor activity e.g., ORR.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lead COM902 ClinInfo
Phone
‪+1 415 373 0781
Email
COM902-001@cgen.com
First Name & Middle Initial & Last Name or Official Title & Degree
Backup COM902 ClinInfo
Phone
+1 415 373 0781
Email
COM902-001@cgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
COM902 Study Director COM902 Study Director
Organizational Affiliation
Compugen Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Florida Cancer Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
COM902 Study Director
Phone
415-373-0781
Email
COM902-001@cgen.com
Facility Name
Massachusetts General Hospital.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
COM902 Study Director
Phone
415-373-0781
Email
COM902-001@cgen.com
Facility Name
START Midwest.
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
COM902 Study Director
Phone
415-373-0781
Email
COM902-001@cgen.com
Facility Name
The Ohio State University Comprehensive Cancer Center.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
COM902 Study Director
Phone
415-373-0781
Email
COM902-001@cgen.com
Facility Name
The University of Tennessee WEST Cancer Center.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
COM902 Study Director.
Phone
415-373-0781
Email
COM902-001@cgen.com
Facility Name
Mary Crowley Cancer Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
COM902 Study Director.
Phone
415-373-0781
Email
COM902-001@cgen.com
Facility Name
MD Anderson Cancer Center.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
COM902 Study Director
Phone
415-373-0781
Email
COM902-001@cgen.com
Facility Name
The START Center for Cancer Care.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
COM902 Study Director
Phone
415-373-0781
Email
COM902-001@cgen.com
Facility Name
Froedtert & Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
COM902 Study Director
Phone
415-373-0781
Email
COM902-001@cgen.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies

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