NCT06132113

Brief Summary

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 Part A1, Part A2, and Part B. Part A1 of this study aims to find out the highest dose of BI 764532 that people can tolerate in addition to chemotherapy. Part A2 of this study is to find out how well people tolerate a low dose of BI 764532 combined with the 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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1

Timeline
12mo left

Started Jan 2024

Typical duration for phase_1

Geographic Reach
8 countries

19 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2024Apr 2027

First Submitted

Initial submission to the registry

November 10, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 22, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

November 10, 2023

Last Update Submit

April 27, 2026

Conditions

Neuroendocrine Neoplasms

Outcome Measures

Primary Outcomes (3)

  • Part A1: Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period

    Up to 21 days.

  • Part A2: Reduced monitoring: the occurrence of DLTs during the on-treatment period

    Up to 36 months.

  • Part B: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period

    Up to 36 months.

Secondary Outcomes (6)

  • Part A1: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period

    Up to 36 months.

  • Part A1: Occurrence of adverse events (AEs) during the on-treatment period

    Up to 36 months.

  • Part A2: Occurrence of adverse events (AEs) during the on-treatment period

    Up to 36 months.

  • Part A2: Objective response (OR)

    Up to 36 months.

  • Part B: Objective response (OR)

    Up to 36 months.

  • +1 more secondary outcomes

Study Arms (6)

Part A1: BI 764532 low dose + carboplatin + etoposide

EXPERIMENTAL
Drug: BI 764532Drug: CarboplatinDrug: Etoposide

Part A1: BI 764532 medium dose + carboplatin + etoposide

EXPERIMENTAL
Drug: BI 764532Drug: CarboplatinDrug: Etoposide

Part A1: BI 764532 high dose + carboplatin + etoposide

EXPERIMENTAL
Drug: BI 764532Drug: CarboplatinDrug: Etoposide

Part B: BI 764532 + carboplatin + etoposide

EXPERIMENTAL
Drug: BI 764532Drug: CarboplatinDrug: Etoposide

Part B: BI 764532 + cisplatin + etoposide

EXPERIMENTAL
Drug: BI 764532Drug: EtoposideDrug: Cisplatin

Part A2: BI 764532 + carboplatin + etoposide

EXPERIMENTAL
Drug: BI 764532Drug: CarboplatinDrug: Etoposide

Interventions

BI 764532DRUG

BI 764532

Also known as: Obrixtamig
Part A1: BI 764532 high dose + carboplatin + etoposidePart A1: BI 764532 low dose + carboplatin + etoposidePart A1: BI 764532 medium dose + carboplatin + etoposidePart A2: BI 764532 + carboplatin + etoposidePart B: BI 764532 + carboplatin + etoposidePart B: BI 764532 + cisplatin + etoposide
CarboplatinDRUG

Standard of care

Part A1: BI 764532 high dose + carboplatin + etoposidePart A1: BI 764532 low dose + carboplatin + etoposidePart A1: BI 764532 medium dose + carboplatin + etoposidePart A2: BI 764532 + carboplatin + etoposidePart B: BI 764532 + carboplatin + etoposide
EtoposideDRUG

Standard of care

Part A1: BI 764532 high dose + carboplatin + etoposidePart A1: BI 764532 low dose + carboplatin + etoposidePart A1: BI 764532 medium dose + carboplatin + etoposidePart A2: BI 764532 + carboplatin + etoposidePart B: BI 764532 + carboplatin + etoposidePart B: BI 764532 + cisplatin + etoposide
CisplatinDRUG

Standard of care

Part B: BI 764532 + cisplatin + etoposide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Hôpital Louis Pradel

Bron, 69500, France

NOT YET RECRUITING

INS Paoli-Calmettes

Marseille, 13009, France

RECRUITING

Klinikum der Universität München AÖR

München, 81377, Germany

NOT YET RECRUITING

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

RECRUITING

Aichi Cancer Center Hospital

Aichi, Nagoya, 464-8681, Japan

RECRUITING

National Cancer Center Hospital East

Chiba, Kashiwa, 277-8577, Japan

RECRUITING

Osaka International Cancer Institute

Osaka, Osaka, 541-8567, Japan

RECRUITING

National Cancer Center Hospital

Tokyo, Chuo-ku, 104-0045, Japan

RECRUITING

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Sahlgrenska Universitetsjukhuset

Gothenburg, 413 46, Sweden

RECRUITING

Related Links

MeSH Terms

Interventions

CarboplatinEtoposideCisplatin

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127clintriage.rdg@boehringer-ingelheim.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Part A1: Dose escalation, Part A2: Reduced monitoring, Part B: Dose expansion
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2023

First Posted

November 15, 2023

Study Start

January 22, 2024

Primary Completion (Estimated)

February 9, 2027

Study Completion (Estimated)

April 25, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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

Locations

JP(4)DE(2)ES(3)SE(1)BE(1)NL(1)US(5)FR(2)