Clinical trial NCT04354246: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: 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
Lead sponsor: Compugen Ltd
Sponsor class: INDUSTRY
First posted: 2020-04-21
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The safety and tolerability of COM902 monotherapy and in combination with COM701.
timeFrame: DLT evaluation window in the 1st cycle (21 Days).
measure: To identify the maximum tolerated dose (MTD) and/or recommended dose for expansion of COM902 monotherapy and in combination with COM701.
timeFrame: 18 months.
measure: To characterize the pharmacokinetic (PK) profile of COM902 as monotherapy and in combination with COM701.
timeFrame: 18 months.
measure: Evaluation of safety and tolerability of the Triplet combination (COM902 + COM701 + Pembrolizumab).
timeFrame: 18 months.
measure: Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).
timeFrame: 18 months.
measure: Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).
timeFrame: 18 months.
Secondary outcomes:
measure: To characterize immunogenicity of COM902 monotherapy and in combination with COM701.
timeFrame: 18 months.
measure: To characterize the immunogenicity of the Triplet combination (COM902 + COM701 + Pembrolizumab).
timeFrame: 18 months.
Other outcomes:
measure: Evaluation of the preliminary antitumor activity of COM902 as monotherapy and in combination with COM701.
timeFrame: 24 months.
measure: Preliminary antitumor activity of the triplet combination (COM902 + COM701 + Pembrolizumab).
timeFrame: 24 months
Locations:
city: Sarasota
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital.
state: Massachusetts
city: Grand Rapids
country: United States
facility: START Midwest.
state: Michigan
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center.
state: Ohio
city: Memphis
country: United States
facility: The University of Tennessee WEST Cancer Center.
state: Tennessee
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center.
state: Texas
city: San Antonio
country: United States
facility: The START Center for Cancer Care.
state: Texas
city: Milwaukee
country: United States
facility: Froedtert & Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Compugen Ltd
name: COM902 Study Director COM902 Study Director
role: STUDY_DIRECTOR
References: