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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

NCT ID: NCT06132113

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-22

Study Completion Date

2027-04-25

Brief Summary

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This study is open to adults aged 18 and older or above legal age who have a specific type of advanced neuroendocrine cancer (NEC). Their tumours must be positive for a marker called DLL3.

The purpose of this study is to test a medicine called BI 764532 in addition to chemotherapy. The study has 2 parts. Part A of this study aims to find out the highest dose of BI 764532 that people can tolerate in addition to chemotherapy. The purpose of Part B is to find out how well people can tolerate BI 764532 in combination with different chemotherapies. Researchers also want to find out whether BI 764532 in combination with chemotherapy helps people with NEC.

Participants get different doses of BI 764532 as an infusion into a vein. In addition, they get platinum-based chemotherapy as infusions into a vein. Participants can continue treatment up to 3 years if they benefit from treatment and can tolerate it.

Participants visit their doctors regularly. During these visits, the doctors collect information about participants' health and take note of any unwanted effects. Doctors also regularly check the size of the tumour.

Detailed Description

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Conditions

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Neuroendocrine Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Part A: Dose escalation, Part B: Dose expansion
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A: BI 764532 low dose + carboplatin + etoposide

Group Type EXPERIMENTAL

BI 764532

Intervention Type DRUG

BI 764532

Carboplatin

Intervention Type DRUG

Standard of care

Etoposide

Intervention Type DRUG

Standard of care

Part A: BI 764532 medium dose + carboplatin + etoposide

Group Type EXPERIMENTAL

BI 764532

Intervention Type DRUG

BI 764532

Carboplatin

Intervention Type DRUG

Standard of care

Etoposide

Intervention Type DRUG

Standard of care

Part A: BI 764532 high dose + carboplatin + etoposide

Group Type EXPERIMENTAL

BI 764532

Intervention Type DRUG

BI 764532

Carboplatin

Intervention Type DRUG

Standard of care

Etoposide

Intervention Type DRUG

Standard of care

Part B: BI 764532 + carboplatin + etoposide

Group Type EXPERIMENTAL

BI 764532

Intervention Type DRUG

BI 764532

Carboplatin

Intervention Type DRUG

Standard of care

Etoposide

Intervention Type DRUG

Standard of care

Part B: BI 764532 + cisplatin + etoposide

Group Type EXPERIMENTAL

BI 764532

Intervention Type DRUG

BI 764532

Etoposide

Intervention Type DRUG

Standard of care

Cisplatin

Intervention Type DRUG

Standard of care

Interventions

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BI 764532

BI 764532

Intervention Type DRUG

Carboplatin

Standard of care

Intervention Type DRUG

Etoposide

Standard of care

Intervention Type DRUG

Cisplatin

Standard of care

Intervention Type DRUG

Other Intervention Names

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Obrixtamig

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Miami

Miami, Florida, United States

Site Status RECRUITING

Winship Cancer Institute

Atlanta, Georgia, United States

Site Status RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status NOT_YET_RECRUITING

John Theurer Cancer Center

Hackensack, New Jersey, United States

Site Status NOT_YET_RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status RECRUITING

HOP Louis Pradel

Bron, , France

Site Status NOT_YET_RECRUITING

INS Paoli-Calmettes

Marseille, , France

Site Status RECRUITING

Klinikum der Universität München AÖR

München, , Germany

Site Status NOT_YET_RECRUITING

Universitätsklinikum Tübingen

Tübingen, , Germany

Site Status RECRUITING

Aichi Cancer Center Hospital

Aichi, Nagoya, , Japan

Site Status RECRUITING

National Cancer Center Hospital East

Chiba, Kashiwa, , Japan

Site Status RECRUITING

Osaka International Cancer Institute

Osaka, Osaka, , Japan

Site Status RECRUITING

National Cancer Center Hospital

Tokyo, Chuo-ku, , Japan

Site Status RECRUITING

Universitair Medisch Centrum Groningen

Groningen, , Netherlands

Site Status RECRUITING

Hospital Universitari Vall D Hebron

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario La Paz

Madrid, , Spain

Site Status RECRUITING

Sahlgrenska Universitetsjukhuset

Gothenburg, , Sweden

Site Status RECRUITING

Akademiska hospital

Uppsala, , Sweden

Site Status NOT_YET_RECRUITING

Countries

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United States Belgium France Germany Japan Netherlands Spain Sweden

Central Contacts

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Boehringer Ingelheim

Role: CONTACT

Phone: 1-800-243-0127

Email: [email protected]

Facility Contacts

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Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Related Links

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https://www.mystudywindow.com

Related Info

Other Identifiers

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U1111-1292-1400

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-505870-13-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

1438-0007

Identifier Type: -

Identifier Source: org_study_id