Back to Search

A First -in Human Phase I, Non-randomized, Open-label, Multi-center Dose Escalation Trial of BI 764532 Administered by Repeated Intravenous Infusions in Patients With Small Cell Lung Carcinoma and Other Neuroendocrine Neoplasms Expressing DLL3

  • Protocol Number: 202009216
  • Principal Investigator: Morgensztern, Daniel
  • Cancer Types: Lung

Learn more about this study at: clinicaltrials.gov

For more information on this trial, contact us here:

Phone
800-600-3606
Email
info@ccadmin.wustl.edu

Brief Summary

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 phase Ia.

The Phase Ib objectives, endpoints and design will be specified in a study protocol amendment after availability of phase Ia results.

Protocol Interventions

BI 764532