NCT03667716

COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.

A Phase 1a/1b Study of COM701 as Monotherapy and In Combination With an Anti-PD-1 Antibody in Subjects With Advanced Solid Tumors.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Compugen Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary clinical activity of COM701 as monotherapy and in combination with nivolumab.

Detailed description

This Phase 1 study evaluates the safety, tolerability, Pharmacokinetics (PK) and preliminary clinical activity of COM701 an inhibitor of poliovirus receptor related immunoglobulin domain containing (PVRIG) as monotherapy and in combination with nivolumab in subjects with advanced solid tumors. Cohort expansion will be explored evaluating COM701 monotherapy and in combination with nivolumab in subjects with the following select tumor types (Non-Small cell lung cancer (NSCLC), Ovarian, Breast (including Triple negative breast cancer (TNBC) and endometrial cancer. Other tumor types such as CRC-MSS, CRC-KRAS mutant will be enrolled based on emerging clinical activity data.

Conditions

• Advanced Cancer
• Ovarian Cancer
• Breast Cancer
• Lung Cancer
• Endometrial Cancer
• Ovarian Neoplasm
• Triple Negative Breast Cancer
• Lung Neoplasm
• Neoplasm Malignant
• Colo-rectal Cancer

Interventions

Type	Name	Description
DRUG	COM701	COM701 monotherapy.
DRUG	COM701 with Opdivo (Nivolumab).	COM701 in combination with Opdivo (Nivolumab).

Timeline

• Start date: 2018-09-06
• Primary completion: 2024-01-30
• Completion: 2024-01-30
• First posted: 2018-09-12
• Last updated: 2025-01-17

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study