Experimental combo aims to boost immune attack on tough lung cancers
NCT ID NCT05879978
First seen Jun 26, 2026 · Last updated Aug 05, 2026 · Updated 3 times
Summary
This early-stage trial tests two drugs, obrixtamig and ezabenlimab, given together as infusions to adults with advanced small cell lung cancer or other neuroendocrine tumors that have a specific marker called DLL3. The main goal is to find the highest safe dose of obrixtamig when combined with ezabenlimab. Up to 45 participants will receive treatment for up to 3 years, with regular monitoring for side effects and tumor response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Obrixtamig (BI 764532) and ezabenlimab
- What this could lead to
- If this combination is safe and shows signs of shrinking tumors, it could point toward a new treatment option for people with advanced small cell lung cancer or other neuroendocrine cancers that have stopped responding to standard therapy.
- What could go wrong
- This is a very early (Phase 1) trial with only 45 participants, so the main goal is safety and dosing, not proof of effectiveness. The drugs may cause side effects, and there is no guarantee they will work against the cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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45 people
The number who actually took part.
- Started
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Jun 2023
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria 1. Age ≥18 years 2. Signed and dated, written informed consent form (main ICF) in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses. 3. Diagnosed with locally advanced, metastatic or relapsed cancer not amenable to curative treatment of the 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 Delta-like 3 (DLL3) expression (on archived tissue) according to central pathology review in order to start obrixtamig. * Patients with tumors 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 tumor tissue. 4. Patient who failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease. Previous therapies should include at least one line of platinum-based chemotherapy. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 6. At least one evaluable lesion outside of Central Nervous System (CNS) as defined per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 7. Subjects with brain metastases are eligible provided they meet the following criteria: * radiotherapy or surgery for brain metastases was completed at least 2 weeks or 4 weeks respectively, 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 CNS disease. 8. Male or female patients. Women of childbearing potential (WOCBP)1 and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.These methods must be used during the study and for at least 3 months after the last dose of obrixtamig. A list of contraception methods meeting these criteria is provided in the patient information. Further inclusion criteria apply. Exclusion criteria 1. Previous treatment with T-cell-engager (TcE) or cell therapies targeting DLL3. Other DLL3 targeting agents (like RovaT) are allowed only if DLL3 positivity is documented after completion of treatment with DLL3 targeting agent in post-treatment biopsy. 2. Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except: * effectively treated non-melanoma skin cancers * effectively treated carcinoma in situ of the cervix * effectively treated ductal carcinoma in situ * other effectively treated malignancy that is considered cured by local treatment 3. Major injuries and/or surgery or bone fracture within 28 days of first dose obrixtamig, or planned surgical procedures 4. Known leptomeningeal disease or spinal cord compression due to metastatic disease 5. Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed 6. Patients who have been febrile, have had leukocytosis, or any clinical signs of infection within 48 h prior to randomization/start of trial treatment are not eligible. Oral or intravenous antimicrobials for management of fungal, bacterial, viral, or other infection are prohibited within 7 days prior to randomization/start of trial treatment. The use of antimicrobials for routine infection prophylaxis is acceptable 7. Severe acute respiratory syndrome coronavirus 2 (SARS COV2) infection within 2 weeks prior to study entry (confirmed via Polymerase chain reaction (PCR) test or other applicable test as per local requirements) or suspected SARS-CoV-2 infection as per physician assessment, or close contact (within 1 week) with an individual with confirmed SARS-CoV-2 infection 8. Any of the following known laboratory evidence of hepatitis virus infection: * Positive results of hepatitis B surface (HBs) antigen * Presence of hepatitis B core (HBc) antibody together with hepatitis B virus (HBV)-Deoxyribonucleic Acid (DNA) * Presence of hepatitis C Ribonucleic acid (RNA) Further exclusion criteria apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CTR François Baclesse
Caen, 14000, France
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Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
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Hôpital Louis Pradel
Bron, 69677, France
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INS Claudius Regaud IUCT-Oncopole
Toulouse, 31059, France
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National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045, Japan
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Technische Universität Dresden
Dresden, 01307, Germany
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Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
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Universitätsklinikum Frankfurt
Frankfurt, 60590, Germany
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