Phase 1 Trial Amendment for Pembrolizumab + Penetrium™ in Refractory/Recurrent Solid Tumors
Phase 1 clinical trial plan change application (manufacturing site change, formulation change)
Target diseases: solid tumors including NSCLC and triple-negative breast cancer
Primary objective: Determine MTD and DLT (3-week cycle)
Target enrollment: minimum 3 to maximum 24 patients
Trial site: Ajou University Hospital (multi-center)
Statistical probability of success is approximately 10%
Exclusive license for PenetriumTM held by Hyundai Bioscience
KOSDAQ Filing Information
Filing: Key Management Matters Related to Investment Decision (Application for Approval of Clinical Trial Plan Change) ((Phase 1 Clinical Trial Plan Change Approval Application for Pembrolizumab and Penetrium Combination Therapy in Refractory/Recurrent Solid Tumors))