For Healthcare Professionals

COM701 in Combination With BMS-986207 and Nivolumab in Subjects With Advanced Solid Tumors.

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About the study

This is a phase 1/2 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of COM701 in combination with BMS-986207 and nivolumab in patients with advanced solid tumors.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key Inclusion Criteria:


  1. Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy and has exhausted all available standard therapy or is not a candidate for the available standard therapy.
  2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  3. During dose escalation - Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti- CTLA-4, OX-40, CD137, etc., are eligible.

During cohort expansion: All subjects must have measurable disease as defined by RECIST v1.1.


Expansion Cohorts:


  1. Cohort 1 (subjects with advanced epithelial ovarian, fallopian tube, or primary peritoneal carcinoma)
  2. Subject must have platinum refractory/resistant ovarian cancer defined as refractoriness to platinum-containing regimen or disease recurrence < 6 months after completion of a platinum-containing regimen
  3. Cohort 2 (endometrial cancer cohort)
  4. Subjects with locally advanced or metastatic microsatellite stable endometrial cancer with disease recurrence or progression during or after prior therapy that included platinum-based chemotherapy.
  5. Subjects must have documented MSS status by an approved test e.g. genomic testing, IHC for mismatch repair proficient.
  6. Subjects must have received no more than 2 prior systemic cytotoxic therapies; there are no limits to the number of prior endocrine or antiangiogenic regimens
  7. Cohort 3 (basket cohort, excludes tumor types in cohorts 1 and 2)
  8. Tumor types with high expression of PVRL2 (determined by central testing).
  9. Cohort 4 (Head and Neck cancer)
  10. Histologically confirmed recurrent or metastatic HNSCC (oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, paranasal sinus, nasopharyngeal)
  11. Cohort 4a - IO naïve. Eligible subjects can be systemic therapy naïve (frontline) or platinum failure.
  12. Cohort 4b - IO failure. No limitations on the number of prior lines of systemic therapy.

EXCLUSION CRITERIA

Key Exclusion Criteria:


  1. Active autoimmune disease requiring systemic therapy in the last 2 years prior to the first dose of COM701.
  2. Symptomatic interstitial lung disease or inflammatory pneumonitis.
  3. History of immune-related events that lead to immunotherapy treatment discontinuation.
  4. Untreated or symptomatic central nervous system (CNS) metastases.

Key Exclusion Criteria For Dose Expansion Cohorts:


  1. Cohort 1: Prior therapy with an anti-PD-1/PD-L1/2, COM701 (or any inhibitor of PVRIG), anti-TIGIT antibody, anti-CTLA-4 antibody, anti-OX-40 antibody, anti-CD137 antibody.
  2. Cohort 2: Prior therapy with COM701 (or any inhibitor of PVRIG) or anti-TIGIT antibody. Subjects with MSI-H endometrial cancer are ineligible.
  3. Cohort 3: Prior therapy with COM701 (or any inhibitor of PVRIG) or anti-TIGIT antibody are ineligible.
  4. Cohort 4: Subjects who have received prior therapy with COM701 (or any inhibitor of PVRIG), anti-TIGIT antibody, anti-CTLA-4 antibody, anti-OX-40 antibody, anti-CD137 antibody. Subjects in cohort 4a must be IO-naïve.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Endometrial Neoplasms,Ovarian Cancer,Solid Tumor,Head and Neck Cancer

Age (in years)

18+

Phase

Phase 1/Phase 2

Participants needed

100

Est. Completion Date

Dec 31, 2023

Treatment type

Interventional


Sponsor

Compugen Ltd

ClinicalTrials.gov identifier

NCT04570839

Study number

CPG-03-101

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