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

Boehringer Ingelheim0 sites19 target enrollmentAugust 11, 2020

Overview

No summary available.

Registry

who.int

Start Date

August 11, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•\* Signed and dated, written informed consent form (ICF2\) in accordance with ICH\-GCP and local legislation prior to any trial\-specific procedures, sampling, or analyses.
•\* Locally advanced or metastatic cancer not amenable to curative treatment; of following histologies:
•\- Small cell lung carcinoma (SCLC)
•\- Large cells neuroendocrine lung carcinoma(LCNEC)
•\- Neuroendocrine carcinoma (NEC) or small cell carcinoma of any other origin
•Tumours must be positive for DLL3 expression (on archived tissue or in\-study biopsy) according to central pathology review in order to start BI 764532\.
•\* Patient has failed or is not eligible for available standard therapies according to local guidelines. Standard therapies should include at least one line of chemotherapy that should include platinum for patients with small cells carcinoma tumors histologies.
•\* For back\-fill cohorts only: patient has agreed to and signed an IC to provide pre\-treatment and on\-treatment fresh tumor biopsy (fresh pre\- and on\-treatment biopsies are optional for main dose escalation patients).
•\* At least one evaluable lesion outside of CNS as defined per modified RECIST 1\.1\.
•\* Adequate liver, bone marrow and renal organ function

•\* Previous treatment with T cells engagers or cell therapies targeting DLL3\.
•\* Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed (e.g. biopsy).
•\* Persistent toxicity from previous treatments that has not resolved to \<\= CTCAE Grade1 (except for alopecia, CTCAE Grade 2 neuropathy, asthenia/fatigue or grade 2 endocrinopathies controlled by replacement therapy).
•\* Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of BI 764532\. Physiological replacement of steroids is allowed.
•\* Prior anti\-cancer therapy:
•\- Patients who have been treated with any other anti\-cancer drug within 3 weeks or within 5 half\-life periods (whichever is shorter) prior to first administration of BI 764532\.
•\- Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532\.
•\* Women who are pregnant, nursing/breast feeding or who plan to become pregnant or nurse while in the trial or within 3 months after the last dose of study treatment.