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Priya Life Science Compound trial record
Compound · clinical trials

Obrixtamig clinical trials

Also listed in trial records as BI 764532, BI 764532, 1, BI 764532, 2, Obrixtamig - parenteral 1, Obrixtamig - parenteral 2
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 12 trials in our Germany, USA, France, Spain, Japan, Belgium, Netherlands, Poland, UK, China, Australia, Sweden, Switzerland, Austria, Portugal, South Korea, Taiwan, Italy, Czechia, Norway, Canada, Brazil, Mexico, Ireland, Turkey, Singapore, Denmark and Israel registers that name Obrixtamig as an intervention. Synced 9 Nov 2026
12Current trials
6Recruiting now
1Lead sponsor
28Country registers
At a glance

Obrixtamig is named as an intervention in 12 current clinical trials in our Germany, USA, France, Spain, Japan, Belgium, Netherlands, Poland, UK, China, Australia, Sweden, Switzerland, Austria, Portugal, South Korea, Taiwan, Italy, Czechia, Norway, Canada, Brazil, Mexico, Ireland, Turkey, Singapore, Denmark and Israel registers. 6 are recruiting patients now. The most common phase is Phase 1. The lead sponsor is Boehringer Ingelheim. The most-studied condition is Small Cell Lung Carcinoma (SCLC). The EU clinical trials register (CTIS) separately lists 5 authorised or ongoing trials, 1 with a site in Ireland.

Where Obrixtamig is approved

All regulators →
USUnited States (FDA)
No FDA approval of a single-substance product in Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
No new-drug Notice of Compliance since 1994
First new-drug NOC
  • 2 EU orphan designations, most recently for treatment of extrapulmonary neuroendocrine carcinoma (21 Aug 2024, positive)

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

How Obrixtamig works

All drug targets →
Diseases it has been tested for in clinical trials, by furthest phase
  • Small cell lung carcinomaPhase 3
  • Neuroendocrine carcinomaPhase 2
  • Pulmonary large cell neuroendocrine carcinomaPhase 2
  • Brain neoplasmPhase 1
  • GliomaPhase 1
  • Neuroendocrine neoplasmPhase 1

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL6068151, CC BY-SA 3.0. The Guide to Pharmacology has no record of this medicine, so its targets rest on ChEMBL alone. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Obrixtamig

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Trials by status

  • Recruiting650%
  • Not yet open18%
  • Active, closed542%

Trials by phase

  • Phase 1758%
  • Phase 3217%
  • Phase 1/2217%
  • Phase 218%
01

Clinical trials of Obrixtamig

12 trials
StudyPhaseStatusLead sponsorRegisters
DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemoimmunotherapy
NCT07472517 · Small Cell Lung Cancer (SCLC), Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Phase 3 Recruiting Boehringer Ingelheim Ireland, UK, USA, China, Germany, France, Spain, Italy, Netherlands, Belgium, Sweden, Poland, Switzerland, Austria, Czechia, Norway, Portugal, Turkey, Canada, Brazil, Mexico, Japan, South Korea, Taiwan, Singapore, Australia
DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy
NCT07544654 · Extrapulmonary Neuroendocrine Cancer (epNEC)
Phase 3 Recruiting Boehringer Ingelheim UK, USA, China, Germany, France, Spain, Italy, Netherlands, Belgium, Sweden, Denmark, Poland, Austria, Czechia, Norway, Portugal, Canada, Brazil, Mexico, Japan, South Korea, Taiwan, Australia, Israel
DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers
NCT05882058 · Small Cell Lung Carcinoma, Neuroendocrine Neoplasms, Extra-pulmonary Neuroendocrine Carcinoma
Phase 2 Recruiting Boehringer Ingelheim UK, USA, China, Germany, France, Spain, Belgium, Portugal, Japan, South Korea, Taiwan
A Study to Test Obrixtamig in Combination With Pumitamig in People With Advanced Small Cell Lung Cancer (Dareon®-Rosetta35)
NCT07843940 · Extensive-stage Small Cell Lung Carcinoma, Advanced Small Cell Lung Cancer
Phase 1/2 Recruiting Boehringer Ingelheim USA, China, Germany, France, Spain, Netherlands, Belgium, Poland, Japan, Australia
A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With a Tumour in the Brain That is Positive for DLL3
NCT05916313 · Glioma
Phase 1 Recruiting Boehringer Ingelheim USA, Germany, Spain, Netherlands, Switzerland, Austria
A Study to Test How BI 764532 is Taken up by Tumours in People With Small-cell Lung Cancer or Neuroendocrine Cancer
NCT05963867 · ClinicalTrials.gov ↗ · Small Cell Lung Carcinoma (SCLC), Neuroendocrine Neoplasms
Phase 1 Recruiting Boehringer Ingelheim Netherlands
DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers
NCT07707895 · Small Cell Lung Cancer, Large Cell Neuroendocrine Lung Carcinoma, Extrapulmonary Neuroendocrine Carcinoma of Small Cell Histology
Phase 1/2 Not yet open Boehringer Ingelheim UK, USA, China, Germany, France, Spain, Netherlands, Belgium, Poland, Japan, Australia
A Study to Test Different Doses of Obrixtamig in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3
NCT04429087 · Small Cell Lung Carcinoma and Other Neuroendocrine Neoplasms Expressing DLL3
Phase 1 Active, closed Boehringer Ingelheim USA, Germany, Spain, Japan
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
NCT05879978 · ClinicalTrials.gov ↗ · Small Cell Lung Carcinoma (SCLC), Neuroendocrine Neoplasms
Phase 1 Active, closed Boehringer Ingelheim Germany, France, Belgium, Japan
DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With a Single Agent Chemotherapy
NCT05990738 · Small Cell Lung Carcinoma (SCLC)
Phase 1 Active, closed Boehringer Ingelheim UK, USA, Germany, France, Poland
DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer
NCT06077500 · Small Cell Lung Carcinoma (SCLC)
Phase 1 Active, closed Boehringer Ingelheim USA, Germany, France, Spain, Belgium, Poland, Switzerland, Japan
DAREON™-7: A Study to Test How Well Different Doses of BI 764532 in Addition to Chemotherapy Are Tolerated by People With Advanced Neuroendocrine Cancers
NCT06132113 · Neuroendocrine Neoplasms
Phase 1 Active, closed Boehringer Ingelheim USA, Germany, France, Spain, Netherlands, Belgium, Sweden, Japan

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Obrixtamig in the EU trials register (CTIS)

5 trials · 1 in Ireland

Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Obrixtamig. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.

StudyPhaseStatusSponsorCountries
DAREON®-Lung-1: A Phase III multi-center, open-label, randomised trial of intravenous obrixtamig in combination with atezolizumab, carboplatin, and etoposide vs. atezolizumab, carboplatin, and etoposide as first-line treatment in patients with extensive-stage small cell lung cancer.
2025-520565-51-00 · Neoplasms
Phase 3 Ongoing Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A Ireland + 19 more
A Phase Ib/II, open-label, safety and tolerability trial of intravenous obrixtamig in combination with pumitamig and standard of care (carboplatin, etoposide) in patients with extensive stage small cell lung carcinoma.
2026-525459-99-00 · CTIS ↗ · Neoplasms
Phase 1 Authorised Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A Germany, Spain, France + 3 more
A Phase Ib/II, open-label, safety and tolerability trial of obrixtamig in combination with ZL-1310 in patients with poorly differentiated NEC
2026-525634-27-00 · CTIS ↗ · Neoplasms
Phase 1 Ongoing Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A Poland, France, Belgium + 3 more
A Phase II, single-arm trial on the addition of the DLL3xCD3 bispecific T-cell engager obrixtamig (BI 764532) to standard-of-care platinum-based first-line treatment of advanced large-cell neuroendocrine carcinoma of the lung (ALPINE 2)
2025-524345-28-00 · Neoplasms
Phase 2 Authorised Technische Universitaet Dresden Germany
A Phase III, multi-center, open-label, randomised, controlled trial of intravenous obrixtamig in combination with carboplatin and etoposide vs. carboplatin and etoposide as first-line therapy in DLL3-positive patients with unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinomas.
2025-523869-22-00 · CTIS ↗ · Neoplasms
Phase 3 Ongoing Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A Portugal, Spain, Poland + 11 more
03

Conditions studied with Obrixtamig

15 conditions
Small Cell Lung Carcinoma (SCLC)4Neuroendocrine Neoplasms4Small Cell Lung Cancer (SCLC)1Extensive-stage Small Cell Lung Cancer (ES-SCLC)1Small Cell Lung Cancer1Large Cell Neuroendocrine Lung Carcinoma1Extrapulmonary Neuroendocrine Carcinoma of Small Cell Histology1Extrapulmonary Neuroendocrine Carcinoma of Large Cell Histology1Extrapulmonary Neuroendocrine Cancer (epNEC)1Small Cell Lung Carcinoma1Extra-pulmonary Neuroendocrine Carcinoma1Extensive-stage Small Cell Lung Carcinoma1
All 15 conditions
Condition (as registered)Trials
Small Cell Lung Carcinoma (SCLC)4
Neuroendocrine Neoplasms4
Small Cell Lung Cancer (SCLC)1
Extensive-stage Small Cell Lung Cancer (ES-SCLC)1
Small Cell Lung Cancer1
Large Cell Neuroendocrine Lung Carcinoma1
Extrapulmonary Neuroendocrine Carcinoma of Small Cell Histology1
Extrapulmonary Neuroendocrine Carcinoma of Large Cell Histology1
Extrapulmonary Neuroendocrine Cancer (epNEC)1
Small Cell Lung Carcinoma1
Extra-pulmonary Neuroendocrine Carcinoma1
Extensive-stage Small Cell Lung Carcinoma1
Advanced Small Cell Lung Cancer1
Glioma1
Small Cell Lung Carcinoma and Other Neuroendocrine Neoplasms Expressing DLL31
06

Related compounds

07

Questions about Obrixtamig trials

How many clinical trials are testing Obrixtamig?

12 current trials in our Germany, USA, France, Spain, Japan, Belgium, Netherlands, Poland, UK, China, Australia, Sweden, Switzerland, Austria, Portugal, South Korea, Taiwan, Italy, Czechia, Norway, Canada, Brazil, Mexico, Ireland, Turkey, Singapore, Denmark and Israel registers name Obrixtamig (also registered as BI 764532) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.

Are Obrixtamig trials recruiting patients?

Yes. 6 of the 12 trials are recruiting: 5 with sites in Germany, 5 with sites in USA, 4 with sites in France, 5 with sites in Spain, 4 with sites in Japan, 4 with sites in Belgium, 5 with sites in Netherlands, 3 with sites in Poland, 3 with sites in UK, 4 with sites in China, 3 with sites in Australia, 2 with sites in Sweden, 2 with sites in Switzerland, 3 with sites in Austria, 3 with sites in Portugal, 3 with sites in South Korea, 3 with sites in Taiwan, 2 with sites in Italy, 2 with sites in Czechia, 2 with sites in Norway, 2 with sites in Canada, 2 with sites in Brazil, 2 with sites in Mexico, 1 with sites in Ireland, 1 with sites in Turkey, 1 with sites in Singapore, 1 with sites in Denmark and 1 with sites in Israel. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Obrixtamig clinical trials?

The lead sponsor is Boehringer Ingelheim. The number in brackets is how many trials each organisation leads.

Are there Obrixtamig clinical trials in Ireland?

Yes. 1 trial in our Ireland register (ClinicalTrials.gov), and 1 trial in the EU register (CTIS) list a site in Ireland. Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Obrixtamig works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Obrixtamig works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Obrixtamig (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.