Phase 2, Multicenter, Open label, Platform Study investigating ASP3082 in patients with Metastatic/Locally Advanced Non-Small-Cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC), with biomarker analysis to characterize response/resistance (UNLOCK ASP3082)

Condition studied

Metastatic Non-small cell lung cancer (NSCLC) and Pancreatic ductal adenocarcinoma

Investigational medicinal product(s)

Eligibility

Primary endpoint

Best overall response (BOR) based on investigator assessment per RECIST v.1.1

Endpoint detail

Duration of response (DOR)  Clinical benefit rate (CBR)  Progression-free survival (PFS)  Overall survival (OS), Frequency and severity of all adverse events (AEs), treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs), defined by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)  Treatment discontinuation, interruptions, and dose reductions due to any AEs Frequency and severity of laboratory abnormalities defined by NCI-CTCAE v5.0, To evaluate pharmacodynamic changes, proteomic, genomic and other biomarkers that may correlate with treatment outcome  To characterize mechanisms of acquired resistance correlating with treatment outcome