A phase 1/2, first-in-human study on ODM-212 in subjects with selected advanced solid tumours

Neoplasms benign malignant and unspecified (incl cysts and polyps). MedDRA [C04]

Part 1 and 2 of the CT: Incidence, frequency and severity of TEAEs., Part 1 and 2 of the CT: other general safety assessments (laboratory tests, physical examination findings, body temperature, systolic and diastolic BP, 12-lead ECGs incl. HR)

Part 1 of the CT: MTD is defined according to BOIN as the dose for which the estimated toxicity rate (the rate of DLTs) is closest to the target toxicity rate of 25%. A DLT is defined as an event related to ODM- 212 as judged by the investigator and/or the SMB, occurring during the DLT period., Part 1 of the CT: Dose selection based on MTD, DLT, TEAEs, clinical and laboratory assessments., Part 1 of the CT: ODM-212 concentrations and PK variables (Day 1: AUCt, AUC0-12, AUC0-24, AUC∞, λz, Vz/F, Cl/F, t1/2, Cmax, Tmax; Day 15: AUCt, AUC0-12, AUC∞, λz, t1/2, Cmax, Cav, Tmax, Rac,obs)., Part 1 of the CT: Antitumour activity is assessed based on: Clinical benefit rate (CBR) at week 8, as best response of either complete response (CR), partial response (PR), or stable disease (SD) at week 8. CBR, as best response of either CR, PR, or at least 8 weeks of SD. Objective response rate (ORR) as response of either CR or PR. CBR and ORR will be assessed according to RECIST v. 1.1Antitumour activity is also assessed based on change from baseline in ECOG performance status., Part 1 and 2 of the CT: OS will be assessed throughout the study and a survival sweep will be performed 1 year after LSLV., Part 1 and 2 of the CT: ORR i.e. the rate of CR and/or PR by the investigator according to RECIST v. 1.1 (modified RECIST for MPM)., Part 1 and 2 of the CT: The CBR defined as: as best response of CR and/or PR and/or SD at week 8; as best response of CR and/or PR and/or at least 8 weeks of SD by RECIST v. 1.1 (modified RECIST for MPM)., Part 2 of the CT: PFS will be assessed by the investigator according to RECIST v. 1.1 (modified RECIST for MPM)., Part 2 of the CT: ECOG performance status, CBR, duration of objective response, clinical disease progression., Dose selection based on safety, exposure, and all other available nonclinical, clinical, PK and biomarker data.

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