Study of Obrixtamig for Small Cell Lung Cancer and Other Neuroendocrine Tumors
This study is for adults with advanced small cell lung cancer or other neuroendocrine cancers that have a specific marker called DLL3. These are cancers for which previous treatments haven't worked or there are no standard options. The main goal is to find the highest dose of obrixtamig that people can tolerate and the best way to give it. Obrixtamig is a drug designed to help your immune system fight cancer. You would receive obrixtamig either once a week or once every three weeks. This study is currently looking for about 300 participants.
- Study design
- This is an interventional study testing different doses of obrixtamig. It aims to enroll about 300 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure maximum tolerated dose and dose-limiting toxicities for up to 36 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04429087
A Study to Test Different Doses of Obrixtamig in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3
Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatmentBoehringer Ingelheim
~300 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Obrixtamig - parenteral 1Obrixtamig - parenteral 2
At a glance
Recruiting sites
0 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Arm 1 and Arm 2: Maximum tolerated dose (MTD)
Measured over up to 36 months
+1 more outcome measured
Conditions
Where it's being run
12 sites across 7 statesSpain4
Germany3
Georgia1
Maryland1
Missouri1
Pennsylvania1
Japan1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Signed and dated, written informed consent form (ICF2, ICF3 or ICF4) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.
Locally advanced or metastatic cancer not amenable to curative treatment; of following histologies:
Small cell lung carcinoma (SCLC)
Large cells neuroendocrine lung carcinoma (LCNEC)
Neuroendocrine carcinoma (NEC) or small cell carcinoma of any other origin
Tumours must be positive for DLL3 expression (on archived tissue or instudy fresh biopsy) according to central pathology review in order to start obrixtamig
Patients with tumours with mixed histologies for any above type are eligible only if neuroendocrine carcinoma/small tumor cells component is predominant and represent at least 50% of the overall tumour tissue.
For back-fill cohorts only: patient has agreed to and signed an IC to provide mandatory pre-treatment and on-treatment fresh tumor biopsy.
Patient has failed or is not eligible for available standard therapies according to local guidelines. Standard therapies should include at least one line of chemotherapy that should include platinum for patients with small cells carcinoma tumors histologies.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
At least one evaluable lesion outside of CNS as defined per modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Subjects with brain metastases are eligible provided they meet the following criteria:
Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of obrixtamig
Patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant Central Nervous System (CNS) disease.
Exclusion
Previous treatment with T cell Engager (TcE) or cell therapies targeting DLL3. Other DLL3 targeting agents (like Rovalpituzumab tesirine (RovaT)) are allowed only if DLL3 positivity is documented after completion of treatment with DLL3 targeting agent in post-treatment biopsy.
Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed (e.g. biopsy).
Persistent toxicity from previous treatments that has not resolved to = Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, CTCAE Grade 2 neuropathy, asthenia/fatigue or grade 2 endocrinopathies controlled by replacement therapy).
Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of obrixtamig. Physiological replacement of steroids is allowed.
Prior anti-cancer therapy:
Patients who have been treated with any other anti-cancer drug within 3 weeks or within 5 half-life periods (whichever is shorter) prior to first administration of obrixtamig.
Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of obrixtamig.
Other active malignancy that could interfere with the prognosis and treatment of the disease of the study.
Major surgery within 28 days of first dose obrixtamig.
Women who are pregnant (including those who are considered to be possibly pregnant based on the investigator's clinical judgement), nursing/breast feeding or who plan to become pregnant or nurse while in the trial or within 60 days after the last dose of study treatment.
Presence of any infection requiring systemic antimicrobial treatment within 7 days prior to first dose of trial medication. Patients who have any clinical signs of infection within 48 h prior to first dose of trial medication are not eligible.
What this trial measures
- Arm 1 and Arm 2: Maximum tolerated dose (MTD)up to 36 months
Maximum tolerated dose (MTD) in any studied regimen defined as the highest dose with less than 25% risk of the true Dose Limiting Toxicity (DLT) rate being equal or above 33% during the MTD evaluation period. Separate MTDs will be determined for each Regimen.
- Arm 1 and Arm 2: Number of patients with DLTs in the MTD evaluation periodup to 36 months