BI1438-0009 (DAREON 9)

Part A À Dose escalation;The dose escalation part will characterize the dose toxicity curve of;BI 764532 combined with topotecan in patients with SCLC by;escalation of BI 764532 with overdose control. The primary;objective is to determine the maximum tolerated dose (MTD) and/or;recommended dose for expansion (RDE)/recommended Phase II;dose (RP2D) for BI 764532 in combination with topotecan at its;approved dose. The secondary objective is to evaluate the;BI 764532 dose-tolerability relationship during the on-treatment;period.;Part B À Dose confirmation;The dose confirmation part will assess the safety, tolerability, and;efficacy of the BI 764532 RDE/RP2D combined with topotecan in;patients with SCLC. The primary objective of the doseconfirmation;part is to confirm safety and tolerability of BI 764532;in combination with topotecan at the RDE/RP2D. The secondary;objective is to assess the efficacy of BI 764532 in combination with;topotecan (objective response and duration of response).