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PhIb BI 764532 Given Monotherapy Administered by Repeated Intravenous Infusions in Pa w/Glioma DLL3

Cancer
Daniela Bota
A Phase Ib Open-Label, Multi-Center, Dose Escalation Trial of BI 764532 Given as Monotherapy Administered by Repeated Intravenous Infusions in Patients with Glioma Expressing DLL3
Brain and Nervous System

Study Description

A Phase Ib open-label, multi-center, dose escalation trial of

BI 764532 given as monotherapy administered by repeated

intravenous infusions in patients with glioma expressing DLL3

Eligibility

Eligibility Criteria

-Signed and dated written informed consent form (ICF1 and ICF2) in accordance with ICH-GCP and local legislation prior to admission to the trial

  • Tumours must be positive for DLL3 expression (defined as staining in >50% of tumour cells) by IHC on archived tumour tissue according to central pathology review
  • Adequate liver, bone marrow, and renal function

-Presence of extracranial metastatic or leptomeningeal disease

  • Previous treatment with therapies targeting DLL3

-Prior treatment with bevacizumab or other anti-VEGF or

anti-angiogenic treatment within 6 months prior to first

administration of BI 764532

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