To determine the maximum tolerated dose(s) (MTD) or the Recommended Dose for Expansion (RDE) and dosing regimen for further development of BI 764532. The MTDs will be defined based on the frequency of patients experiencing dose limiting toxicities (DLTs) during the MTD evaluation period in studied regimens. The Recommended Dose for Expansion (RDE) will be guided by overall safety, efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) assessments. Additional objectives are to document the safety and tolerability of BI 764532, to characterise pharmacokinetics and pharmacodynamics, and to evaluate efficacy signals. Phase Ib will further explore BI 764532 in selected patients populations based on data from phase Ia. The Phase Ib objectives, endpoints and design will be specified in a study protocol amendment after availability of phase Ia results.
To determine the maximum tolerated dose(s) (MTD) or recommended dose for expansion (RDE) and dosing regimen for the advancement of BI 764532. MTDs will be defined based on the frequency of patients experiencing dose-limiting toxicities (DLTs) during the MTD evaluation period in the regimens studied. The recommended dose for expansion (RDE) will be guided by assessments of overall safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD). Additional objectives include documenting the safety and tolerability of BI 764532, characterizing pharmacokinetics and pharmacodynamics, and evaluating efficacy signals. In Phase Ib, BI 764532 will be further investigated in selected patient populations based on data from Phase Ia. The objectives, endpoints and design of Phase Ib will be defined in an amendment to the study protocol once the results of Phase Ia are available.
