A Study to Test Different Doses of Obrixtamig in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3
Part of paid clinical trials in Atlanta, Georgia.
- Sponsor
- Boehringer Ingelheim
- Study ID
- NCT04429087
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Small Cell Lung Carcinoma and Other Neuroendocrine Neoplasms Expressing DLL3
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Obrixtamig - parenteral 1 — DRUGObrixtamig - parenteral 1
- Obrixtamig - parenteral 2 — DRUGObrixtamig - parenteral 2
Study Details
This study is open to adults with small cell lung cancer and other neuroendocrine cancers 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 and the best treatment schedule that people can tolerate. Obrixtamig is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. In this study, obrixtamig is given to people for the first time. Interim clinical data are available for obrixtamig. Participants get obrixtamig either weekly or once every 3 weeks. 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 20 times depending on the response to the treatment. Doctors record any unwanted effects and regularly check the general health of the participants.
Key Dates
- Start date
- Jul 29, 2020
- Status verified
- May 2026
- Primary completion
- Sep 1, 2026
- Completion
- Feb 15, 2027
Study Design
- Enrollment
- 300 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm 1: Obrixtamig
- Experimental: Arm 2: Obrixtamig
Primary Outcome Measure
Arm 1 and Arm 2: Maximum tolerated dose (MTD) [ Time Frame: up to 36 months ]
Central Contacts
- Boehringer Ingelheim1-800-243-0127
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Winship Cancer Institute | Atlanta | Georgia | 30322 | |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | |
| Washington University School of Medicine | St Louis | Missouri | 63108 | |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | - |