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Experimental drug duo aims to boost immune attack on tough cancers

NCT ID NCT07707895

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Sep 03, 2026 · Updated 8 times

Summary

This study tests a combination of two experimental drugs, obrixtamig and ZL-1310, designed to help the immune system fight cancer. It is for adults with advanced small cell lung cancer or other neuroendocrine cancers. The trial has two parts: the first finds a safe dose of the two-drug combo, and the second adds a third drug (a checkpoint inhibitor) to see if the combination is tolerable and can stop cancer growth. Participants receive the drugs as infusions and are monitored for up to two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a combination of two experimental drugs: obrixtamig and ZL-1310, sometimes with atezolizumab
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced neuroendocrine cancers, potentially slowing tumor growth.
What could go wrong
This is an early-phase trial with a small number of participants, so the benefits and risks are not yet well understood. The combination may cause significant side effects or may not work better than existing treatments.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: For Part 1 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 2. 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 3. 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 4. 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. 5. 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 6. 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 7. 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) 8. 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 9. Further inclusion criteria apply. Exclusion criteria: 1. 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 2. Patients with a diagnosis of Merkel cell carcinoma or medullary thyroid cancer 3. Presence of leptomeningeal disease and/or carcinomatous meningitis 4. 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 5. 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 6. 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) 7. 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. 8. Prior organ or tissue allograft 9. Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

large cell neuroendocrine carcinoma pulmonary large cell neuroendocrine carcinoma small cell carcinoma small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Extrapulmonary neuroendocrine carcinoma of large cell histology Extrapulmonary neuroendocrine carcinoma of small cell histology Large cell neuroendocrine lung carcinoma Small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amsterdam UMC Locatie VUMC

    Amsterdam, 1081HV, Netherlands

  • CTR Leon Berard

    Lyon, 69373, France

  • Chris Obrien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • HOP Timone

    Marseille, 13385, France

  • Hokkaido Cancer Center

    Hokkaido, Sapporo, 003-0804, Japan

  • Hospital Clinico De Valencia (INCLIVA)

    Valencia, 46010, Spain

  • Hospital Duran i Reynals

    L'Hospitalet Del Llobregat, 08908, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Institut Gustave Roussy

    Villejuif, 94800, France

  • Kansai Medical University Hospital

    Osaka, Hirakata, 573-1191, Japan

  • Leicester Royal Infirmary

    Leicester, LE1 5WW, United Kingdom

  • Lower Silesian Oncology Centre

    Wroclaw, 53439, Poland

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007, United States

  • Robert Bosch Gesellschaft für medizinische Forschung mbH

    Stuttgart, 70376, Germany

  • Shanghai Chest Hospital

    Shanghai, 200030, China

  • Shanghai Pulmonary Hospital

    Shanghai, 200433, China

  • Shizuoka Cancer Center

    Shizuoka, Sunto-gun, 411-8777, Japan

  • St. Marianna University Hospital

    Kanagawa, Kawasaki, 216-8511, Japan

  • Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza

    Brzozów, 36-200, Poland

  • The Affiliated Cancer Hospital, Guangxi Medical University

    Nanning, 530021, China

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536, United States

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131, Germany

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