Actively Recruiting
A Study to Test Different Doses of Obrixtamig in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3
Led by Boehringer Ingelheim · Updated on 2026-05-12
300
Participants Needed
12
Research Sites
341 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Test Different Doses of Obrixtamig in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Diagnosis of locally advanced or metastatic cancer of the following types: small cell lung carcinoma, large cell neuroendocrine lung carcinoma, neuroendocrine carcinoma or small cell carcinoma of any origin
- Tumor tests positive for DLL3 expression verified by central pathology
- Mixed tumors eligible if neuroendocrine/small cell component is predominant and at least 50% of tumor tissue
- For back-fill groups, agreement to provide mandatory pre-treatment and on-treatment fresh tumor biopsies
- Failed or not eligible for standard treatments including at least one chemotherapy line with platinum for small cell carcinoma
- Eastern Cooperative Oncology Group performance status of 0 or 1
- At least one measurable tumor lesion outside the central nervous system
- Patients with brain metastases eligible if radiotherapy or surgery completed at least 2 weeks before treatment, off steroids for at least 7 days, and stable or no anti-epileptic drugs for malignant CNS disease
- Adequate liver, bone marrow, and kidney function
You will not qualify if you...
- Prior treatment with T cell Engager or cell therapies targeting DLL3
- Anticoagulant treatment that cannot be safely stopped if medically needed
- Ongoing toxicities from previous treatments not resolved to mild or better except specific controlled conditions
- Diagnosis of immunodeficiency or recent systemic steroid or immunosuppressive therapy within 7 days before first dose
- Anti-cancer therapy within 3 weeks or 5 half-lives prior to first dose
- Extensive field radiotherapy including whole brain irradiation within 2 weeks before first dose
- Other active cancers that could interfere with prognosis or treatment
- Major surgery within 28 days before first dose
- Pregnant, breastfeeding, or planning pregnancy during or shortly after study
- Infection requiring systemic antimicrobial treatment within 7 days before first dose or clinical signs of infection within 48 hours prior to dosing
- Additional exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Actively Recruiting
3
Washington University School of Medicine
St Louis, Missouri, United States, 63108
Actively Recruiting
4
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Completed
5
Universitätsklinikum Köln (AöR)
Cologne, Germany, 50937
Completed
6
Technische Universität Dresden
Dresden, Germany, 01307
Actively Recruiting
7
Universitätsklinikum Würzburg AÖR
Würzburg, Germany, 97078
Actively Recruiting
8
National Cancer Center Hospital East
Chiba, Kashiwa, Japan, 277-8577
Actively Recruiting
9
Hospital del Mar
Barcelona, Spain, 08003
Actively Recruiting
10
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
11
Clínica Universidad de Navarra
Pamplona, Spain, 31008
Actively Recruiting
12
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here