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Completed

NCT Number: NCT04354246

COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies

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.

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Key information

Conditions

Advanced Cancer Adnexal Diseases Blood Protein Disorders Carcinoma Carcinoma, Squamous Cell Cardiovascular Diseases Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders HNSCC Head and Neck Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Lymphoproliferative Disorders MSS-CRC Microsatellite Stable Colorectal Carcinoma Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Plasma Cell Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Paraproteinemias Plasma Cell Neoplasm Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Carcinoma of Head and Neck Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Florida Cancer Specialists, Sarasota, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dose escalation: COM902 monotherapy.

Drug

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

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

Combination Product

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.

Cohort expansion: COM902 (RDFE) monotherapy.

Drug

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).

Drug

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.

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

Combination Product

Triplet combination of COM902 + COM701 + Pembrolizumab administered IV every 3 weeks.

Primary outcomes

  1. The safety and tolerability of COM902 monotherapy and in combination with COM701.

    Time frame: 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).

  2. To identify the maximum tolerated dose (MTD) and/or recommended dose for expansion of COM902 monotherapy and in combination with COM701.

    Time frame: 18 months.

    Evaluation of a dose of COM902 monotherapy and in combination with COM701 that is well tolerated by subjects.

  3. To characterize the pharmacokinetic (PK) profile of COM902 as monotherapy and in combination with COM701.

    Time frame: 18 months.

    Evaluation of parameters of COM902 monotherapy or in combination with COM701 exposure such as Maximum Plasma Concentration [Cmax]).

  4. Evaluation of safety and tolerability of the Triplet combination (COM902 + COM701 + Pembrolizumab).

    Time frame: 18 months.

    Incidence of subjects on the Triplet combination (COM902 + COM701 + Pembrolizumab) with Adverse Events (AEs) per CTCAE v5.0.

  5. Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).

    Time frame: 18 months.

    Evaluation of PK parameters e.g., Cmax.

  6. Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).

    Time frame: 18 months.

    Evaluation of PK parameters e.g., AUC.

Secondary outcomes

  1. To characterize immunogenicity of COM902 monotherapy and in combination with COM701.

    Time frame: 18 months.

    Evaluation of anti drug antibody to COM902 (monotherapy) or COM902, COM701 when administered in combination.

  2. To characterize the immunogenicity of the Triplet combination (COM902 + COM701 + Pembrolizumab).

    Time frame: 18 months.

    Evaluation of antidrug antibody to COM902, COM701.

Other outcomes

  1. Evaluation of the preliminary antitumor activity of COM902 as monotherapy and in combination with COM701.

    Time frame: 24 months.

    An assessment of preliminary antitumor activity eg ORR with COM902 monotherapy and COM902 in combination with COM701.

  2. Preliminary antitumor activity of the triplet combination (COM902 + COM701 + Pembrolizumab).

    Time frame: 24 months

    Assessment of preliminary antitumor activity e.g., ORR.

Sponsors and collaborators

Lead sponsor

Compugen Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2020
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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