162TiP A phase I study evaluating BI 765063, a first in class selective myeloid SIRPa inhibitor, as standalone and in combination with BI 754091, a programmed death-1 (PD-1) inhibitor, in patients with advanced solid tumours

This study comprises a dose escalation (step 1) to determine the Dose-Limiting Toxicities, Maximum Tolerated Dose (MTD), and Recommended phase II Dose (RP2Ds) of BI 765063 monotherapy and with BI 754091, and dose-confirmation expansion cohorts (step 2). In Step 1, ascending doses of BI 763063 every 3 weeks intravenously (iv) using a Bayesian approach with overdose control are tested. When MTD determined, BI 763063 will be tested with BI 754091, a PD-1 mAb inhibitor. In step 2, 2 parallel randomized, non-comparative mono and combination cohorts will further confirm the RP2Ds and assess the safety and preliminary efficacy (RECIST 1.1 and iRECIST). Patients ≥ 18 years, PS:0-1, with advanced solid tumor who failed or are not eligible to standard therapy will be included. V1/V1 and V1/V2 patients (central testing) are evaluated in separate cohorts in step 1. In step 2 selected population of V1/V1 patients with selected advanced-stage cancers will be in cluded. Pharmacokinetics (PK), SIRPα receptor occupancy (RO) and a comprehensive translational program (in blood and tumour) will assess PK/PD profile and biomarkers of activity. The trial is currently active and will include 116 patients (56 in step 1 and 60 in step 2).Clinical trial identificationEudraCT: 2018-003830-34; Release date 1 October 2018.Legal entity responsible for the studyOSE Immunotherapeutics.FundingOSE Immunotherapeutics in collaboration with Boehringer Ingelheim.DisclosureA. Marabelle: Advisory / Consultancy: ...
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research