A 2-part phase 1/2 open-label trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ODM-212 in combination with anti-cancer therapy in participants with advanced solid tumours

Condition studied

Neoplasms benign malignant and unspecified (incl. cysts and polyps)

Investigational medicinal product(s)

Eligibility

Primary endpoint

Part 1: Incidence of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and clinical laboratory abnormalities (incl. electrocardiogram [ECG])., Part 2: Incidence of TEAEs, SAEs and clinical laboratory abnormalities (incl. ECG).

Endpoint detail

Part 1: Efficacy evaluations: objective response rate (ORR), duration of response (DOR), disease control rate (DCR), progression-free survival (PFS) and duration of stable disease will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Part 1: ODM-212 concentrations and pharmacokinetic (PK) variables (including but not limited to Cmax, AUCt, AUC0-24) on the last day of cycle 1 or 2, Part 2: ORR, per RECIST 1.1, DOR, DCR, clinical benefit rate (CBR), PFS and overall survival (OS)., Part 2: Dose selection based on safety, exposure, and all other available nonclinical, clinical, PK and biomarker data., Part 2: ODM-212 concentrations and PK variables (including but not limited to Cmax, AUCt, AUC0-24) on the last day of cycle 1.