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New drug combo targets rare, aggressive cancer in early trial

NCT ID NCT06132113

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 9 times

Summary

This early-phase trial tests a new drug called BI 764532 (Obrixtamig) given together with standard chemotherapy for people with advanced neuroendocrine carcinoma (NEC), a rare and fast-growing cancer. The study involves about 55 adults whose tumors have a specific marker (DLL3). The main goals are to find a safe dose and see if the combination helps shrink tumors. Participants receive infusions of the drug plus chemo for up to 3 years if they benefit.

What this could mean

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

Active substance
BI 764532 (Obrixtamig) plus platinum-based chemotherapy (carboplatin or cisplatin) and etoposide
What this could lead to
If it works, this could point toward a new treatment option for advanced neuroendocrine carcinoma, a rare and aggressive cancer.
What could go wrong
This is an early Phase 1 trial with only 55 participants, so safety and dosing are the main focus. The combination may cause significant side effects, and it is too early to know if it will improve outcomes.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

65 people

The number who actually took part.

Started

Jan 2024

Expected to finish

Dec 2027

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: * 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) * Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses * Patients diagnosed with locally advanced or metastatic NEC of following subtypes: * extrapulmonary neuroendocrine carcinomas (epNEC) * pulmonary large cell NEC (LCNEC) * neuroendocrine carcinomas (NEC) of unknown primary site * Patients with tumours with mixed histologies for any above type are eligible only if neuroendocrine carcinoma/small tumour cells component is predominant and represent at least 50% of the overall tumour tissue * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Minimum life expectancy of 12 weeks * At least one measurable lesion as defined per RECIST 1.1 within approximately 35 days prior to the first dose of BI 764532 * Patients with a history of asymptomatic Central nervous system (CNS) metastases are eligible, provided they meet all of the following criteria: * No radiotherapy (including whole brain radiation therapy, stereotactic radiotherapy or radiosurgery) within 7 days * Are neurologically stable without the need for steroids or anti-convulsants for at least 7 days before first dose of BI 764532 as per local site assessment Further inclusion criteria apply. Exclusion Criteria: * Previous treatment in this trial * Current enrolment in another investigational device or drug trial, or \<30 days since ending another investigational device or drug trial(s) * Patients with diagnosis of Merkel cell carcinoma or medullary thyroid carcinoma or Grade 3 neuroendocrine tumour * Presence of leptomeningeal carcinomatosis * Previous treatment with DLL3-targeting T cell engagers and cell therapies * Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532 * Major surgery (major according to the investigator's assessment) within 28 days prior to first administration of BI 764532 or planned during treatment period, e.g. hip replacement Any documented active or suspected malignancy or history of malignancy within 5 years prior to Screening (other than the target indication or well differentiated neuroendocrine tumour (NET) stages of the target indication in case of transformed tumors), except for appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

cancer of unknown primary site neuroendocrine carcinoma neuroendocrine neoplasm pulmonary large cell neuroendocrine carcinoma

As listed by the trial registrant

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

Neuroendocrine neoplasms

Contacts and locations

Locations

  • Aichi Cancer Center Hospital

    Aichi, Nagoya, 464-8681, Japan

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Hopital Louis Pradel

    Bron, 69500, France

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • INS Paoli-Calmettes

    Marseille, 13009, France

  • John Theurer Cancer Center

    Hackensack, New Jersey, 07601, United States

  • Klinikum der Universität München AÖR

    München, 81377, Germany

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045, Japan

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577, Japan

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567, Japan

  • Sahlgrenska Universitetsjukhuset

    Gothenburg, 413 46, Sweden

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ, Netherlands

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650, Belgium

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

  • Uppsala University Hospital

    Uppsala, 751 85, Sweden

  • Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

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