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
- Conditions
- Neuroendocrine NeoplasmsSmall Cell Lung Carcinoma (SCLC)
- Interventions
- Registration Number
- NCT05879978
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description obrixtamig + ezabenlimab treatment group Obrixtamig 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). obrixtamig + ezabenlimab treatment group Ezabenlimab 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 Measures
Name Time Method Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period up to 19 months
- Secondary Outcome Measures
Name Time Method Occurrence of DLTs during the on-treatment period up to 19 months Objective response, defined as best overall response of complete response (CR) or partial response (PR) up to 19 months Objective response, defined as best overall response of complete response (CR) or partial response (PR), where best overall response is determined by the investigator's assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 in patients with measurable disease from date of first treatment administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent
Cmax (maximum measured concentration of obrixtamig) up to 19 months Cmax (maximum measured concentration of ezabenlimab) up to 19 months AUCτ (area under the concentration-time curve of obrixtamig over a uniform dosing interval τ) up to 19 months AUCτ (area under the concentration-time curve of ezabenlimab) over a uniform dosing interval τ) up to 19 months
Trial Locations
- Locations (8)
INS Claudius Regaud IUCT-Oncopole
🇫🇷Toulouse, France
Brussels - UNIV Saint-Luc
🇧🇪Bruxelles, Belgium
CTR François Baclesse
🇫🇷Caen, France
UNIV UZ Gent
🇧🇪Gent, Belgium
HOP Louis Pradel
🇫🇷Bron, France
Technische Universität Dresden
🇩🇪Dresden, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Germany
National Cancer Center Hospital
🇯🇵Tokyo, Chuo-ku, Japan