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
Study ID
NCT05879978
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Neuroendocrine Neoplasms
  • Small Cell Lung Carcinoma (SCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Obrixtamig — DRUG
    Obrixtamig
  • Ezabenlimab — DRUG
    Ezabenlimab

Study Details

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.

Key Dates

Start date
Jun 27, 2023
Status verified
Apr 2026
Primary completion
Jun 11, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: obrixtamig + ezabenlimab treatment group
    Successive cohorts of patients will receive increasing doses of obrixtamig in combination with ezabenlimab until the maximum tolerated dose (MTD) is reached, or upon decision of Dose Escalation Committee (DEC).

Primary Outcome Measure

Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period [ Time Frame: up to 19 months ]

Related Studies