A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for Delta-Like Ligand 3 (DLL3).

STATUS

Recruiting
participants needed

110
sponsor

Boehringer Ingelheim

Updated on 19 February 2024

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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 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.

Details

Condition	Patients With Small Cell Lung Carcinoma and Other Neoplasms
Age	18years - 100years
Treatment	BI 764532
Clinical Study Identifier	NCT04429087
Sponsor	Boehringer Ingelheim
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Signed and dated, written informed consent form (ICF2) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (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 instudy fresh biopsy) according to central pathology review in order to start BI 764532
	Patients with tumours with mixed histologies for any above type are eligible only if neuroendocrine carcinoma/small tumor cells component is predominant and represent at least 50% of the overall tumour tissue
	For back-fill cohorts only: patient has agreed to and signed an IC to provide mandatory pre-treatment and on-treatment fresh tumor biopsy
	Patient has failed or is not eligible for available standard therapies according to local guidelines. Standard therapies should include at least one line of platinum based chemotherapy
	Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
	At least one evaluable lesion outside of CNS as defined per modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
	Subjects with brain metastases are eligible provided they meet the following criteria
	Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 764532
	Patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant Central Nervous System (CNS) disease
	Adequate liver, bone marrow and renal organ function Futher inclusion criteria apply
Exclusion Criteria
	Previous treatment with T cell Engager (TcE) or cell therapies targeting Delta-Like Ligand 3 (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 Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (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
	Other active malignancy that could interfere with the prognosis and treatment of the disease of the study
	Major surgery within 28 days of first dose BI 764532
	Women who are pregnant, nursing/breast feeding or who plan to become pregnant while in the trial
	Further exclusion criteria apply

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A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for Delta-Like Ligand 3 (DLL3).

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A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for Delta-Like Ligand 3 (DLL3).

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