COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies

C

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

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)

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.

Trial contacts and locations

9

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Central trial contact

Backup COM902 ClinInfo; Lead COM902 ClinInfo

Data sourced from clinicaltrials.gov

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