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 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
The Phase Ib objectives, endpoints and design will be specified in a study protocol amendment
after availability of phase Ia results.
Patients With Small Cell Lung Carcinoma and Other Neoplasms
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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