Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination with Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open-label Phase IA/IB Study
Objective
Part C Primary Efficacy: ORR as assessed by BICR based on RECIST 1.1 after the patient receives first ONC-392 treatment either as monotherapy or as combination therapy with pembrolizumab.
Safety: Incidence of TEAEs
Secondary Efficacy parameters: ORR, DoR, BoR and DCR. Exploratory Additional Efficacy parameters: PFS as assessed by the Investigator based on RECIST 1.1 and iRECIST. OS following administration of ONC-392. ORR, DoR, BoR and disease control rate (DCR) as assessed by the BICR based on iRECIST. Exposure-response correlation: PK parameters
