Small Cell Lung CancerPhase 1/2NCT07707895
DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers
A Phase 1/2 study testing Obrixtamig, ZL-1310 and Atezolizumab in people with Small Cell Lung Cancer and Large Cell Neuroendocrine Lung Carcinoma, run by Boehringer Ingelheim at 27 sites in 11 countries.
Trial summary
This study is open to adults with advanced small cell lung cancer and other neuroendocrine cancers. The study has 2 parts. The purpose of Part 1 is to find a suitable dose of a combination study treatment, obrixtamig and ZL-1310. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer, Large Cell Neuroendocrine Lung Carcinoma, Extrapulmonary Neuroendocrine Carcinoma of Small Cell Histology
- What is being tested?
- Obrixtamig, ZL-1310 and Atezolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 27 sitesin 11 countries
- Study dates
- 28 Oct 2026to 26 Apr 2030
- Phase
- Phase 1/2
- 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
- For Part 1
- Diagnosed with locally advanced, metastatic or relapsed cancer of the following histologies:
- Small cell lung carcinoma (SCLC)
- Large cell neuroendocrine lung carcinoma (LCNEC-L)
- Extrapulmonary neuroendocrine carcinoma (epNEC) of small or large cell histology
- Patients with tumours with mixed histologies for any above type are eligible only if the neuroendocrine carcinoma/small cell component is predominant and represents at least 50% of the overall tumour tissue
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- Patients for whom no therapy of proven efficacy exists or who are not eligible for established treatment options. Patients 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, unless there is a documented medical reason not to use platinum
- For Part 2
- Histologically or cytologically confirmed extended stage small cell lung cancer (ES-SCLC) (excluding combined histologies) using the American Joint Committee on Cancer (AJCC) tumour node metastasis staging system combined with Veterans Administration Lung Study Group (VALG)'s two stage classification scheme.
- Patients must have received no prior systemic therapy for ES-SCLC. Participants with prior chemoradiotherapy for Limited stage small cell lung cancer (LS-SCLC) must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible
- For both Part 1 and Part 2
- Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses
- Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF)
- Willing and able to comply with scheduled visits, treatment schedule, the planned trial assessments, laboratory tests, restrictions regarding prohibited medications, lifestyle restrictions, and other requirements related to the trial. This includes that they are able to understand and follow trial-related instructions
- Further inclusion criteria apply.
Who cannot join
- Serious concomitant disease or medical condition such as neurologic, psychiatric (including substance use disorder), active ulcers (gastrointestinal tract or skin) or laboratory abnormalities that may negatively impact patient safety during trial participation, affect compliance with trial requirements or invalidate assessments relevant for the investigation of the safety and preliminary efficacy of the investigational drugs
- Patients with a diagnosis of Merkel cell carcinoma or medullary thyroid cancer
- Presence of leptomeningeal disease and/or carcinomatous meningitis
- Known hypersensitivity to the trial drugs or their excipients, prior severe, life-threatening hypersensitivity reaction(s) to monoclonal antibodies, or significant risk of allergic or anaphylactic reaction(s) to any of the investigated drug products according to the investigator's judgement
- Participants who experienced severe, life-threatening immune-mediated adverse events, e.g. serious Grade 3 or higher immune-related adverse event (imAE) or infusion-related reactions, that led to permanent discontinuation while on treatment with immuno-oncology agents
- Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, asthenia/fatigue, amenorrhea/menstrual disorders, CTCAE Grade 2 peripheral neuropathy, and CTCAE Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks, per investigator judgment)
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- Therapy with any of the following types of treatments or drugs within the noted time intervals prior to IMP administration: At any time: treatment with delta-like ligand 3 (DLL3)-targeting therapies or received more than 30 Gy of thoracic radiotherapy.
- Prior organ or tissue allograft
- Further exclusion criteria apply.
Trial locations and contacts
27 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
27 sites in 11 countries
Japan4 sites
Hokkaido Cancer Center
Hokkaido, Sapporo, 003-0804
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
St. Marianna University Hospital
Kanagawa, Kawasaki, 216-8511
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Kansai Medical University Hospital
Osaka, Hirakata, 573-1191
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Shizuoka Cancer Center
Shizuoka, Sunto-gun, 411-8777
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
United States3 sites
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
China3 sites
The Affiliated Cancer Hospital, Guangxi Medical University
Nanning, 530021
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Shanghai Chest Hospital
Shanghai, 200030
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Shanghai Pulmonary Hospital
Shanghai, 200433
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
France3 sites
CTR Leon Berard
Lyon, 69373
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
HOP Timone
Marseille, 13385
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Institut Gustave Roussy
Villejuif, 94800
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Spain3 sites
Hospital Duran i Reynals
L'Hospitalet Del Llobregat, 08908
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Hospital Universitario 12 de Octubre
Madrid, 28041
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Hospital Clinico De Valencia (INCLIVA)
Valencia, 46010
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Australia2 sites
Chris Obrien Lifehouse
Camperdown, New South Wales, 2050
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Belgium2 sites
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Universitair Ziekenhuis Gent
Ghent, 9000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Germany2 sites
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Robert Bosch Gesellschaft für medizinische Forschung mbH
Stuttgart, 70376
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Poland2 sites
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Brzozów, 36-200
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Lower Silesian Oncology Centre
Wroclaw, 53439
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
United Kingdom2 sites
Leicester Royal Infirmary
Leicester, LE1 5WW
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Netherlands1 site
Amsterdam UMC Locatie VUMC
Amsterdam, 1081HV
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
About this study
Official title: A Phase Ib/II, Open-label, Safety and Tolerability Trial of Obrixtamig in Combination With ZL-1310 in Patients With Poorly Differentiated NEC
This study is open to adults with advanced small cell lung cancer and other neuroendocrine cancers. The study has 2 parts. The purpose of Part 1 is to find a suitable dose of a combination study treatment, obrixtamig and ZL-1310. The purpose of Part 2 is to see how obrixtamig and ZL-1310 is tolerated when given with another medicine called a checkpoint inhibitor. Another purpose is to check whether the study treatment can stop the cancer from growing and keep it stable. Obrixtamig and ZL-1310 are being developed to help the immune system fight cancer.
In Part 1, participants get obrixtamig and ZL-1310. In Part 2, participants get obrixtamig and ZL-1310 with a checkpoint inhibitor. Part 2 is only open to people with advanced small cell lung cancer. All study treatments are given as infusions into a vein.
The study does not have a fixed duration. Participants can receive study treatment for up to 2 years if they benefit from treatment and can tolerate it. Participants visit the study site regularly, with some overnight stays required. During this time, doctors regularly check for health problems that could be caused by the study treatment. They also monitor the size of the tumour(s) and take laboratory tests.
- Conditions
- Small Cell Lung Cancer, Large Cell Neuroendocrine Lung Carcinoma, Extrapulmonary Neuroendocrine Carcinoma of Small Cell Histology, Extrapulmonary Neuroendocrine Carcinoma of Large Cell Histology
- Being tested
- Obrixtamig, ZL-1310, Atezolizumab
- 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
Obrixtamig
ZL-1310Drug
ZL-1310
AtezolizumabDrug
Atezolizumab
| Study group | Role | What they receive |
|---|---|---|
| Part 1: obrixtamig + ZL-1310 (dosing regimen 1) | Experimental | Not described Receives: Drug: Obrixtamig; Drug: ZL-1310 |
| Part 1: obrixtamig + ZL-1310 (dosing regimen 2) | Experimental | Not described Receives: Drug: Obrixtamig; Drug: ZL-1310 |
| Part 2: obrixtamig + ZL-1310 + atezolizumab | Experimental | Not described Receives: Drug: Obrixtamig; Drug: ZL-1310; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: The occurrence of dose limiting toxicities (DLTs) during the DLT evaluation period
Measured: 6 weeks from the first administration of study medication.
Part 2: The occurrence of treatment-emergent adverse events (AEs) leading to trial medication discontinuation or dose modification
Measured: Up to 24 months.
Part 2: PFS rate at 6 months
Progression-free survival (PFS) is defined as the time from first investigational medicinal product (IMP) administration until the earliest date of disease progression according to Response Evaluation Criteria In Solid Tumours (RECIST 1.1) based on investigator assessments or death from any cause, whichever occurs first.
Measured: At 6 months.
Secondary outcomes (8)
Part 1 and Part 2: Occurrence of treatment-emergent DLTs
Measured: Up to 24 months.
Part 1 and Part 2: Occurrence of treatment-emergent adverse event of special interest (AESIs)
Measured: Up to 24 months.
Part 1 and Part 2: Occurrence of treatment-emergent AEs CTCAE Grade ≥3
AEs CTCAE = Adverse events Common Terminology Criteria for Adverse Events
Measured: Up to 24 months.
Part 1 and Part 2: Objective response (OR)
OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 (based on investigator assessments) from the first IMP administration until the earliest date of disease progression, death, last evaluable tumour assessment before the start of the next line of anti-cancer treatment, loss to follow-up, or withdrawal of consent.
Measured: Up to 24 months.
Part 1 and Part 2: Duration of response (DoR)
DoR is defined as the time from the first documented objective response (OR) according to RECIST 1.1 until the earliest date of disease progression or death among patients with confirmed objective response based on investigator assessments.
Measured: Up to 24 months.
Part 1 and Part 2: Disease control (DC)
DC is defined as best overall response of complete response (CR) or partial response (PR) or stable disease (SD) where best overall response is defined according to RECIST version 1.1 based on investigator assessments from the first IMP administration until the earliest date of disease progression, death or last evaluable tumour assessment before start of the next line of anti-cancer treatment, loss to follow-up or withdrawal of consent.
Measured: Up to 24 months.
Part 1: Progression-free survival (PFS)
PFS is defined as the time from first IMP administration until the earliest date of disease progression according to RECIST 1.1 based on investigator assessments or death from any cause, whichever occurs first.
Measured: Up to 24 months.
Part 2: Occurrence of DLTs during the DLT evaluation period
Measured: 6 weeks from the first administration of study medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start28 Oct 2026 (estimated)
- Primary completion26 Apr 2030 (estimated)
- Study completion26 Apr 2030 (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 CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zai Lab
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707895
- Sponsor's protocol ID
- 1438-0036
- Other IDs
- U1111-1334-0148, 2026-525634-27
- Status last verified
- Oct 2026
- First submitted
- 13 Jul 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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 Ib/II, Open-label, Safety and Tolerability Trial of Obrixtamig in Combination With ZL-1310 in Patients With Poorly Differentiated NEC
- ClinicalTrials.gov ID
- NCT07707895
- Acronym / sponsor ID
- 1438-0036
- Conditions
- Small Cell Lung Cancer, Large Cell Neuroendocrine Lung Carcinoma, Extrapulmonary Neuroendocrine Carcinoma of Small Cell Histology, Extrapulmonary Neuroendocrine Carcinoma of Large Cell Histology
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Zai Lab
- Study start
- 28 Oct 2026 (estimated)
- Primary completion
- 26 Apr 2030 (estimated)
- Study completion
- 26 Apr 2030 (estimated)
- First posted
- 16 Jul 2026 (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 advanced small cell lung cancer and other neuroendocrine cancers. The study has 2 parts. The purpose of Part 1 is to find a suitable dose of a combination study treatment, obrixtamig and ZL-1310. The purpose of Part 2 is to see how obrixtamig and ZL-1310 is tolerated when given with another medicine called a checkpoint inhibitor. Another purpose is to check whether the study treatment can stop the cancer from growing and keep it stable. Obrixtamig and ZL-1310 are being developed to help the immune system fight cancer.
In Part 1, participants get obrixtamig and ZL-1310. In Part 2, participants get obrixtamig and ZL-1310 with a checkpoint inhibitor. Part 2 is only open to people with advanced small cell lung cancer. All study treatments are given as infusions into a vein.
The study does not have a fixed duration. Participants can receive study treatment for up to 2 years if they benefit from treatment and can tolerate it. Participants visit the study site regularly, with some overnight stays required. During this time, doctors regularly check for health problems that could be caused by the study treatment. They also monitor the size of the tumour(s) and take laboratory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: obrixtamig + ZL-1310 (dosing regimen 1) | Experimental | Drug: Obrixtamig, Drug: ZL-1310 |
| Part 1: obrixtamig + ZL-1310 (dosing regimen 2) | Experimental | Drug: Obrixtamig, Drug: ZL-1310 |
| Part 2: obrixtamig + ZL-1310 + atezolizumab | Experimental | Drug: Obrixtamig, Drug: ZL-1310, Drug: Atezolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- For Part 1
- Diagnosed with locally advanced, metastatic or relapsed cancer of the following histologies:
- Patients with tumours with mixed histologies for any above type are eligible only if the neuroendocrine carcinoma/small cell component is predominant and represents at least 50% of the overall tumour tissue
- Patients for whom no therapy of proven efficacy exists or who are not eligible for established treatment options. Patients 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, unless there is a documented medical reason not to use platinum
- For Part 2
Key exclusion criteria (9 listed)
- Serious concomitant disease or medical condition such as neurologic, psychiatric (including substance use disorder), active ulcers (gastrointestinal tract or skin) or laboratory abnormalities that may negatively impact patient safety during trial participation, affect compliance with trial requirements or invalidate assessments relevant for the investigation of the safety and preliminary efficacy of the investigational drugs
- Patients with a diagnosis of Merkel cell carcinoma or medullary thyroid cancer
- Presence of leptomeningeal disease and/or carcinomatous meningitis
- Known hypersensitivity to the trial drugs or their excipients, prior severe, life-threatening hypersensitivity reaction(s) to monoclonal antibodies, or significant risk of allergic or anaphylactic reaction(s) to any of the investigated drug products according to the investigator's judgement
- Participants who experienced severe, life-threatening immune-mediated adverse events, e.g. serious Grade 3 or higher immune-related adverse event (imAE) or infusion-related reactions, that led to permanent discontinuation while on treatment with immuno-oncology agents
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 |
|---|---|---|
| ObrixtamigObrixtamig | Drug | Part 1: obrixtamig + ZL-1310 (dosing regimen 1), Part 1: obrixtamig + ZL-1310 (dosing regimen 2), Part 2: obrixtamig + ZL-1310 + atezolizumab |
| ZL-1310ZL-1310 | Drug | Part 1: obrixtamig + ZL-1310 (dosing regimen 1), Part 1: obrixtamig + ZL-1310 (dosing regimen 2), Part 2: obrixtamig + ZL-1310 + atezolizumab |
| AtezolizumabAtezolizumab | Drug | Part 2: obrixtamig + ZL-1310 + atezolizumab |
Primary outcome
Part 1: The occurrence of dose limiting toxicities (DLTs) during the DLT evaluation period
Time frame: 6 weeks from the first administration of study medication.
Part 2: The occurrence of treatment-emergent adverse events (AEs) leading to trial medication discontinuation or dose modification
Time frame: Up to 24 months.
Part 2: PFS rate at 6 months
Time frame: At 6 months.
Progression-free survival (PFS) is defined as the time from first investigational medicinal product (IMP) administration until the earliest date of disease progression according to Response Evaluation Criteria In Solid Tumours (RECIST 1.1) based on investigator assessments or death from any cause, whichever occurs first.
8 secondary outcomes
Part 1 and Part 2: Occurrence of treatment-emergent DLTs
Time frame: Up to 24 months.
Part 1 and Part 2: Occurrence of treatment-emergent adverse event of special interest (AESIs)
Time frame: Up to 24 months.
Part 1 and Part 2: Occurrence of treatment-emergent AEs CTCAE Grade ≥3
Time frame: Up to 24 months.
Part 1 and Part 2: Objective response (OR)
Time frame: Up to 24 months.
Part 1 and Part 2: Duration of response (DoR)
Time frame: Up to 24 months.
Part 1 and Part 2: Disease control (DC)
Time frame: Up to 24 months.
Part 1: Progression-free survival (PFS)
Time frame: Up to 24 months.
Part 2: Occurrence of DLTs during the DLT evaluation period
Time frame: 6 weeks from the first administration of study medication.
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. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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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.
27 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Obrixtamig, ZL-1310 and Atezolizumab in people with Small Cell Lung Cancer and Large Cell Neuroendocrine Lung Carcinoma, run by Boehringer Ingelheim at 27 sites in 11 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 15 inclusion and 9 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: opening soon, 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 27 sites in Japan, United States, China, France, Spain and 6 more countries. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: The occurrence of dose limiting toxicities (DLTs) during the DLT evaluation period (time frame: 6 weeks from the first administration of study medication.). The study lists 3 primary outcomes in all. 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.