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ACTIVE NOT RECRUITING
NCT05879978
PHASE1

A Study to Test How Well Different Doses of Obrixtamig (BI 764532) in Combination With Ezabenlimab Are Tolerated by People With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

This study is open to adults with small cell lung cancer and other neuroendocrine tumours that are positive for the tumour marker Delta-like 3 (DLL3). The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out the highest dose of obrixtamig that people can tolerate when taken together with another medicine called ezabenlimab. Obrixtamig and ezabenlimab may help the immune system fight cancer. Participants get obrixtamig and ezabenlimab as infusions into a vein. If there is benefit for the participants and if they can tolerate it, the treatment is given for a maximum of 3 years. During this time, participants visit the study site about every week. The visits also depend on the response to the treatment. At the study visits, the doctors check the health of the participants, take necessary laboratory tests, and note any health problems that could have been caused by the study treatment.

Official title: A Phase I, Non-randomized, Open-label, Multi-center Dose Escalation Trial of Obrixtamig (BI 764532) Combined With Ezabenlimab in Patients With Small Cell Lung Carcinoma and Other Neuroendocrine Neoplasms Expressing DLL3

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2023-06-27

Completion Date

2026-06-30

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DRUG

Obrixtamig

Obrixtamig

DRUG

Ezabenlimab

Ezabenlimab

Locations (8)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Hôpital Louis Pradel

Bron, France

CTR François Baclesse

Caen, France

INS Claudius Regaud IUCT-Oncopole

Toulouse, France

Technische Universität Dresden

Dresden, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

National Cancer Center Hospital

Tokyo, Chuo-ku, Japan