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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

NCT06132113 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

  • Neuroendocrine Neoplasms

Interventions

DRUG

BI 764532

BI 764532

DRUG

Carboplatin

Standard of care

DRUG

Etoposide

Standard of care

DRUG

Cisplatin

Standard of care

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-22
Primary Completion
2027-02-09
Completion
2027-04-25
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Japan
  • Netherlands
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06132113 on ClinicalTrials.gov