The first patient has been dosed in the P-II study (PRESERVE-004) evaluating ONC-392 (3/6mg/kg) + Keytruda (200mg) in patients with PROC for ~24mos. at the prespecified interval of q3w. The study is sponsored by OncoC4 in collaboration with Merck & GOG Foundation Inc.
The study was based on the promising prior clinical trial results of the monotherapeutic activity of ONC-392. The 1EP of the study is the efficacy measured by ORR per RECIST1.1, and the safety measured by TRAEs and immune-related AEs
ONC-392 is the first known acid pH-sensitive anti-CTLA-4 mAb & is currently being evaluated in late-stage clinical development. The therapy has received FTD from the US FDA as a monotx. for immunotherapy-resistant NSCLC
Ref: Globe Newswire | Image: Novavax
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