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Protocol # 21-060

Status

Active, not recruiting

Description

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.

Condition

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

Interventions

  • COM701 in combination with BMS-986207 and nivolumab.

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • The proportion of subjects with adverse events on the study.
  • The proportion of subjects with adverse events in the 1st cycle during dose escalation within the DLT window (28 days).
  • The recommended dose for expansion (RDFE) of the combination.
  • The Area under the curve of COM701 in subjects receiving the 3-drug combination.

Secondary Outcome:

  • The objective response rate of subjects enrolled in cohorts 1-4.

Enrollment

100

Study Start Date

August 31, 2020

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Compugen Ltd

Source

Compugen Ltd

Official title

A Phase 1/2 Study Evaluating the Safety, Tolerability and Preliminary Antitumor Activity of COM701 in Combination With BMS-986207 (Anti-TIGIT Antibody) and Nivolumab in Subjects With Advanced Solid Tumors.

Clinicaltrials.gov Identifier

NCT04570839

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.