DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers

Conditions

• Extra-pulmonary Neuroendocrine Carcinoma
• Neuroendocrine Neoplasms
• Small Cell Lung Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BI 764532, dose 1 — DRUG
  BI 764532, dose 1
• BI 764532, dose 2 — DRUG
  BI 764532, dose 2

Study Details

This study is open to adults with small cell lung cancer and other neuroendocrine tumours. 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 a suitable dose of BI 764532 (also called obrixtamig) that people with advanced cancer can tolerate. 2 different doses of BI 764532 are tested in this study. Another purpose is to check whether BI 764532 can make tumours shrink. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. The study has 3 parts. In Part 1, participants are put into 2 groups randomly, which means by chance. Participants have an equal chance of being in either group. One group gets dose 1 of BI 764532 and the other group gets dose 2 of BI 764532. In Part 2 and Part 3, all participants receive the same dose of BI 764532. Part 2 and Part 3 are open to people with a certain kind of tumour called extrapulmonary neuroendocrine carcinoma. All participants receive BI 764532 as an infusion into a vein when starting treatment. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. The first study visits include an overnight stay to monitor participants´ safety. Doctors record any unwanted effects and regularly check the general health of the participants.

Key Dates

Start date

Oct 13, 2023

Status verified

Apr 2026

Primary completion

Sep 1, 2027

Completion

Feb 24, 2028

Study Design

Enrollment

204 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Dose group 1
• Experimental: Part 1: Dose group 2
• Experimental: Part 2: Expansion cohort
• Experimental: Part 3: Expansion cohort

Primary Outcome Measure

Part 1: Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) [ Time Frame: up to 26 months ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (16)

Find similar trials in Mobile, AL

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