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NCT06132113 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Neuroendocrine Neoplasms, sponsored by Boehringer Ingelheim.

Recruiting
Registry status
Phase 1
Development phase
55
Enrollment target
20
Study locations

NCT06132113 is a Phase 1 study of Neuroendocrine Neoplasms that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 55 participants, below the 120-participant average among 3 other Neuroendocrine Neoplasms trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 6 states.

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The verdict

NCT06132113, a Phase 1 study of Neuroendocrine Neoplasms, is actively recruiting participants, sponsored by Boehringer Ingelheim.

RECRUITING
Registry status
Phase 1
Development phase
55 participants
Enrollment target
20
Study locations

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 Studied

Neuroendocrine Neoplasms

Interventions

  • DRUG Carboplatin
  • DRUG Cisplatin
  • DRUG Etoposide
  • DRUG BI 764532

Study Locations (20)

Other

  • Cliniques Universitaires Saint-Luc - Brussels
  • HOP Louis Pradel - Bron
  • INS Paoli-Calmettes - Marseille
  • Klinikum der Universität München AÖR - München
  • Universitätsklinikum Tübingen - Tübingen
  • Aichi Cancer Center Hospital - Aichi, Nagoya
  • National Cancer Center Hospital East - Chiba, Kashiwa
  • Osaka International Cancer Institute - Osaka, Osaka
  • National Cancer Center Hospital - Tokyo, Chuo-ku
  • Universitair Medisch Centrum Groningen - Groningen
  • Hospital Universitari Vall D Hebron - Barcelona
  • Hospital Universitario 12 de Octubre - Madrid
  • Hospital Universitario La Paz - Madrid
  • Sahlgrenska Universitetsjukhuset - Gothenburg
  • Akademiska hospital - Uppsala

Florida

  • University of Miami - Miami

Georgia

  • Winship Cancer Institute - Atlanta

Illinois

  • Northwestern University - Chicago

New Jersey

  • John Theurer Cancer Center - Hackensack

Pennsylvania

  • University of Pittsburgh Medical Center - Pittsburgh

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2024-01-22
Est. Completion 2027-04-25
Phase Phase 1

Sponsor

Boehringer Ingelheim

515 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06132113

The ClinicalTrials.gov registry entry for NCT06132113 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 120-participant average among 3 other Neuroendocrine Neoplasms trials with a reported enrollment target (54% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neuroendocrine Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.

NCT06132113 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Other, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT06132113 about?

NCT06132113 is a clinical study titled "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". 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 Pa...

What is the current status of trial NCT06132113?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2024-01-22. Estimated completion is 2027-04-25.

What conditions does trial NCT06132113 study?

This clinical trial studies the following conditions: Neuroendocrine Neoplasms.

What interventions are being tested in trial NCT06132113?

The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Etoposide (DRUG), BI 764532 (DRUG).

Who is sponsoring clinical trial NCT06132113?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06132113 being conducted?

This trial has 20 study locations across Florida, Georgia, Illinois, New Jersey, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.