COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies

Sponsor

Compugen Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04354246

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancer Ovarian Cancer Lung Cancer Colon Cancer Plasma Cell Neoplasm Multiple Myeloma HNSCC	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).	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 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 :

Mar 31, 2020

Anticipated Primary Completion Date :

Jan 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

The safety and tolerability of COM902 monotherapy and in combination with COM701. [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).
To identify the maximum tolerated dose (MTD) and/or recommended dose for expansion of COM902 monotherapy and in combination with COM701. [18 months.]
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. [18 months.]
Evaluation of parameters of COM902 monotherapy or in combination with COM701 exposure such as Maximum Plasma Concentration [Cmax]).

Secondary Outcome Measures

To characterize immunogenicity of COM902 monotherapy and in combination with COM701. [18 months.]
Evaluation of anti drug antibody to COM902 (monotherapy) or COM902, COM701 when administered in combination.

Other Outcome Measures

Evaluation of the preliminary antitumor activity of COM902 as monotherapy and in combination with COM701. [24 months.]
An assessment of preliminary antitumor activity eg ORR with COM902 monotherapy and COM902 in combination with COM701.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	START Midwest.	Grand Rapids	Michigan	United States	49503
2	The Ohio State University Comprehensive Cancer Center.	Columbus	Ohio	United States	43210
3	The University of Tennessee WEST Cancer Center.	Memphis	Tennessee	United States	38138
4	Mary Crowley Cancer Research	Dallas	Texas	United States	75230
5	MD Anderson Cancer Center.	Houston	Texas	United States	77030
6	The START Center for Cancer Care.	San Antonio	Texas	United States	78229