Small Cell Lung Carcinoma (SCLC)Phase 1NCT05879978
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
A Phase 1 study testing Obrixtamig and Ezabenlimab in people with Small Cell Lung Carcinoma (SCLC) and Neuroendocrine Neoplasms, run by Boehringer Ingelheim at 8 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Carcinoma (SCLC), Neuroendocrine Neoplasms
- What is being tested?
- Obrixtamig and Ezabenlimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 27 Jun 2023to 31 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- 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.
- 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
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- 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.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- At least one evaluable lesion outside of Central Nervous System (CNS) as defined per 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 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.
- 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.
Who cannot join
- 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.
- 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
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- Major injuries and/or surgery or bone fracture within 28 days of first dose obrixtamig, or planned surgical procedures
- Known leptomeningeal disease or spinal cord compression due to metastatic disease
- Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed
- 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
- 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
- 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.
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
France3 sites
Hopital Louis Pradel
Bron, 69677
CTR François Baclesse
Caen, 14000
INS Claudius Regaud IUCT-Oncopole
Toulouse, 31059
Belgium2 sites
Cliniques Universitaires Saint-Luc
Brussels, 1200
Universitair Ziekenhuis Gent
Ghent, 9000
Germany2 sites
Technische Universität Dresden
Dresden, 01307
Universitätsklinikum Frankfurt
Frankfurt, 60590
About this study
Official title: A Phase I, Non-randomized, Open-label, Multi-center Dose Escalation Trial of Obrixtamig (BI 764532) Combined With Ezabenlimab in Patients With Small Cell Lung Carcinoma and Other Neuroendocrine Neoplasms Expressing DLL3
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.
- Being tested
- Obrixtamig, Ezabenlimab
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObrixtamigDrug
Also called BI 764532
Obrixtamig
EzabenlimabDrug
Ezabenlimab
| Study group | Role | What they receive |
|---|---|---|
| obrixtamig + ezabenlimab treatment group | Experimental | 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). Receives: Drug: Obrixtamig; Drug: Ezabenlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period
Measured: up to 19 months
Secondary outcomes (6)
Occurrence of DLTs during the on-treatment period
Measured: up to 19 months
Objective response, defined as best overall response of complete response (CR) or partial response (PR)
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
Measured: up to 19 months
Cmax (maximum measured concentration of obrixtamig)
Measured: up to 19 months
Cmax (maximum measured concentration of ezabenlimab)
Measured: up to 19 months
AUCτ (area under the concentration-time curve of obrixtamig over a uniform dosing interval τ)
Measured: up to 19 months
AUCτ (area under the concentration-time curve of ezabenlimab) over a uniform dosing interval τ)
Measured: up to 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start27 Jun 2023
- Primary completion11 Jun 2025
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Carcinoma (SCLC)Studies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879978
- Sponsor's protocol ID
- 1438-0002
- Other IDs
- 2022-502728-30-00
- Status last verified
- Oct 2026
- First submitted
- 25 May 2023
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Non-randomized, Open-label, Multi-center Dose Escalation Trial of Obrixtamig (BI 764532) Combined With Ezabenlimab in Patients With Small Cell Lung Carcinoma and Other Neuroendocrine Neoplasms Expressing DLL3
- ClinicalTrials.gov ID
- NCT05879978
- Acronym / sponsor ID
- 1438-0002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obrixtamig + ezabenlimab treatment group | Experimental | Drug: Obrixtamig, Drug: EzabenlimabSuccessive 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥18 years
- 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.
- Diagnosed with locally advanced, metastatic or relapsed cancer not amenable to curative treatment of the following histologies:
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Key exclusion criteria (15 listed)
- 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.
- Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except:
- Major injuries and/or surgery or bone fracture within 28 days of first dose obrixtamig, or planned surgical procedures
- Known leptomeningeal disease or spinal cord compression due to metastatic disease
- Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObrixtamigAlso: BI 764532Obrixtamig | Drug | obrixtamig + ezabenlimab treatment group |
| EzabenlimabEzabenlimab | Drug | obrixtamig + ezabenlimab treatment group |
Primary outcome
Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period
Time frame: up to 19 months
6 secondary outcomes
Occurrence of DLTs during the on-treatment period
Time frame: up to 19 months
Objective response, defined as best overall response of complete response (CR) or partial response (PR)
Time frame: up to 19 months
Cmax (maximum measured concentration of obrixtamig)
Time frame: up to 19 months
Cmax (maximum measured concentration of ezabenlimab)
Time frame: up to 19 months
AUCτ (area under the concentration-time curve of obrixtamig over a uniform dosing interval τ)
Time frame: up to 19 months
AUCτ (area under the concentration-time curve of ezabenlimab) over a uniform dosing interval τ)
Time frame: up to 19 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Obrixtamig and Ezabenlimab in people with Small Cell Lung Carcinoma (SCLC) and Neuroendocrine Neoplasms, run by Boehringer Ingelheim at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Belgium, Germany, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period (time frame: up to 19 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.