(MAintenance Immunotherapy with an Anti-PVRIG antibody: COM701, as maintenance monotherapy or combination therapy in patients with relapsed platinum sensitive ovarian cancer.)
MAIA-ovarian is a global adaptive platform trial to evaluate the safety and efficacy of COM701 as maintenance monotherapy or combination therapy in patients with relapsed platinum sensitive ovarian cancer. The purpose of sub-trial 1 is to assess if COM701 delays the progression of ovarian cancer in patients with relapsed platinum sensitive ovarian cancer and further assess its safety profile in this disease setting. The adaptive-platform design enables additional sub-trials. Sub-trial 1 is a double-blind, randomized placebo-controlled trial in which 60 patients will be randomized in a 2:1 ratio to COM701 or placebo. Subsequent sub-trials may evaluate COM701 in combination with other anticancer drugs.
Proof of concept study designed to evaluate the simultaneous blockade of three immune checkpoint pathways, PVRIG (COM701), TIGIT (COM902) and PD-1 (pemrolizumab), in patients with platinum resistant ovarian cancer. This study is building on prior data suggesting that blocking PVRIG may sensitize tumors to respond to PD-1 and TIGIT blockade, and could turn cold tumors hot, potentially offering a chemotherapy free option to patients. This is a real potential opportunity to transform the lives of patients with the right immunotherapy combinations.
Compugen also has a clinical stage partnered program, rilvegostomig (previously AZD2936), an Fc reduced PD-1/TIGIT bi-specific derived from Compugen’s COM902. This program is in Phase 3 development by AstraZeneca through a license agreement for the development of bi-specific and multi-specific antibodies. AstraZeneca has specifically designed and engineered rilvegostomig with a unique mechanism of action to harness co-operative binding of both PD-1 and TIGIT to drive enhanced immune responses.
The primary objectives of this Phase 1 trial are to assess the safety and tolerability of GS-0321 as a monotherapy and in combination with zimberelimab in patients with advanced solid tumors and to identify the maximum tolerated dose /maximum administered dose and/or the recommended dose of GS-0321 as monotherapy and in combination with zimberelimab.