Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-21-059
Prinicipal Investigator
Ma, Patrick
Phase
Phase I
Age Group
Adult
Scope
National
Secondary Protocol No.
ONC-392-001
Title
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
Applicable Disease Sites
Lung
Status
Open
Participating Institutions
Hershey Medical Center