Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-21-039
Prinicipal Investigator
Ma, Patrick
Phase
Phase II
Age Group
Adult
Scope
National
Secondary Protocol No.
GCT1046-04
Title
A Phase II, Multicenter, Randomized, Open-Label Trial of GEN1046 as monotherapy and in Combination with Anti-cancer Therapy in Subjects with Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer who failed first-line Standard of Care therapy with an Immune Checkpoint Inhibitor
Objective
OBJECTIVES ENDPOINTS
Primary: Evaluate the anti-tumor activity of GEN1046 as monotherapy and in combination with anti-cancer therapy in subjects with relapsed/refractory metastatic NSCLC

Endpoint: Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by investigator

Secondary: Evaluate time to onset and durability of the anti-tumor response of GEN1046 as monotherapy and in combination with anti-cancer therapy in subjects with relapsed/refractory metastatic NSCLC. Evaluate the clinical benefit of GEN1046 as monotherapy and in combination with anticancer therapy. Assess safety and tolerability of GEN1046 as monotherapy and in combination with anticancer therapy.
Endpoints: Duration of response (DOR) per RECIST v1.1. Time to response (TTR) per RECIST v1.1. Progression-free survival (PFS) per RECIST v1.1. Overall survival (OS). Incidence and severity of adverse events (AEs). Incidence and severity of laboratory abnormalities.
Applicable Disease Sites
Lung
Status
Open
Participating Institutions
Hershey Medical Center