COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies

Lung Cancer Clinical Trial

Official title:

A Phase 1 Study of The Safety and Tolerability of COM902 in Subjects With Advanced Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04354246
• Other study ID #: CPG-02-101
• Status: Recruiting
• Phase: Phase 1
• Start date: March 31, 2020
• Est. completion date: March 30, 2025

Study information

• Verified date: February 2024
• Source: Compugen Ltd
• Contact: Lead COM902 ClinInfo
• Phone: ?+1 415 373 0781
• Email: COM902-001[@]cgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Colon Cancer
• Colorectal Neoplasms
• HNSCC
• Lung Cancer
• Microsatellite Stable Colorectal Carcinoma
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Ovarian Cancer
• Plasma Cell Neoplasm
• Plasmacytoma

Intervention

Drug:
• Dose escalation: COM902 monotherapy.
COM902 monotherapy administered IV every 3 weeks in sequential dose escalation doses in cohorts of subjects.

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.

Drug:
• Cohort expansion: COM902 (RDFE) monotherapy.
COM902 monotherapy (RDFE) in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.
• 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.

Combination Product:
• Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.
Triplet combination of COM902 + COM701 + Pembrolizumab administered IV every 3 weeks.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital.	Boston	Massachusetts
United States	The Ohio State University Comprehensive Cancer Center.	Columbus	Ohio
United States	Mary Crowley Cancer Research	Dallas	Texas
United States	START Midwest.	Grand Rapids	Michigan
United States	MD Anderson Cancer Center.	Houston	Texas
United States	The University of Tennessee WEST Cancer Center.	Memphis	Tennessee
United States	Froedtert & Medical College of Wisconsin	Milwaukee	Wisconsin
United States	The START Center for Cancer Care.	San Antonio	Texas
United States	Florida Cancer Specialists	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Compugen Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of the preliminary antitumor activity of COM902 as monotherapy and in combination with COM701.	An assessment of preliminary antitumor activity eg ORR with COM902 monotherapy and COM902 in combination with COM701.	24 months.
Other	Preliminary antitumor activity of the triplet combination (COM902 + COM701 + Pembrolizumab).	Assessment of preliminary antitumor activity e.g., ORR.	24 months
Primary	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).	DLT evaluation window in the 1st cycle (21 Days).
Primary	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.	18 months.
Primary	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]).	18 months.
Primary	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.	18 months.
Primary	Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).	Evaluation of PK parameters e.g., Cmax.	18 months.
Primary	Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).	Evaluation of PK parameters e.g., AUC.	18 months.
Secondary	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.	18 months.
Secondary	To characterize the immunogenicity of the Triplet combination (COM902 + COM701 + Pembrolizumab).	Evaluation of antidrug antibody to COM902, COM701.	18 months.