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ADVANCED SOLID TUMORS: PHASE 1: ENDOMETRIAL, OVARIAN, Or PVRL2: CPG-03-101

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.

Title
Compugen CPG-03-101 (Ph1 TIGIT + COM)
Study 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.

Site Link
Malignancy
Endometrial, Ovarian, Breast, Lung, Colon, Prostate, Gastric, Esophageal, Cervical, Melanoma, Skin, Pancreas, Pancreatic, Sarcoma, Head and Neck (HNPCC), NSCLC, SCLC, Kidney, Bladder, RCC, Prostate
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
Late line (post standard therapy)
Investigational Agent
COM-701, BMS-986207, nivolumab
Drug Class
PVRIG antagonist, anti-TIGIT Ab, PD-1 antibody
PI
Dan Vaena, MD
Sponsor
Compugen, Ltd
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy and has exhausted all available standard therapy or not a candidate for standard therapy
  • ECOG PS 0-1
  • Prior therapy with immune therapy are eligible (except in ovarian cohort)
  • In Expansion cohorts patients must either have
    • Advanced epithelial cancer of the ovary, fallopian tube, or peritoneum
    • Advanced MSS endometrial cancer
    • A different malignancy that has high expression of PVRL2
  • No active autoimmune disease
  • No interstitial lung disease
  • No active CNS metastases
  • In ovaran cohort, no prior immunotherapy
  • No prior therapy with PVRIG inhibitor or anti-TIGIT antibody
Objective
  • Primary
    • Safety
  • Secondary
    • ORR
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
PVRL2 high (only for basket cohort)
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
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