COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies

Compugen

Status and phase: Enrolling; Phase 1

Conditions: Advanced Cancer; Multiple Myeloma; MSS-CRC; HNSCC; Colon Cancer; Plasma Cell Neoplasm; Lung Cancer; Ovarian Cancer; Microsatellite Stable Colorectal Carcinoma

Treatments: Drug: Cohort expansion: COM902 (RDFE) monotherapy.; Combination Product: Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.; Drug: Dose escalation: COM902 monotherapy.; Combination Product: Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE); Drug: Cohort expansion: COM902 in combination with COM701 (both at the RDFE).

Study type: Interventional

Funder types: Industry

Identifiers

NCT04354246

CPG-02-101

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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110 participants in 6 patient groups

COM902 monotherapy dose escalation.

Experimental group

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.

Treatment:

Drug: Dose escalation: COM902 monotherapy.

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

Experimental group

Description:

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

Treatment:

Combination Product: Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE)

COM902 monotherapy cohort expansion at RDFE.

Experimental group

Description:

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

Treatment:

Drug: Cohort expansion: COM902 (RDFE) monotherapy.

COM902 + COM701 combination cohort expansion both at RDFE.

Experimental group

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.

Treatment:

Drug: Cohort expansion: COM902 in combination with COM701 (both at the RDFE).

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

Experimental group

Description:

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

Treatment:

Combination Product: Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.

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

Experimental group

Description:

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

Treatment:

Combination Product: Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.