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

April 30, 2024 updated by: Boehringer Ingelheim

DAREON™-7: A Phase I, Open-label, Dose Escalation and Expansion Trial to Investigate Safety and Tolerability of BI 764532 Intravenous Infusions in Combination With Standard of Care (Platinum and Etoposide) in First-line Treatment of Patients With Neuroendocrine Carcinomas (NEC)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Tübingen, Germany, 72076
  • Japan
      • Aichi, Nagoya, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center Hospital
        • Contact:
      • Chiba, Kashiwa, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
        • Contact:
      • Osaka, Osaka, Japan, 541-8567
        • Recruiting
        • Osaka International Cancer Institute
        • Contact:
      • Tokyo, Chuo-ku, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
        • Contact:
  • Spain
      • Barcelona, Spain, 08035
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Madrid, Spain, 28046
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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 1 week 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), except for appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix Further exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: BI 764532 low dose + carboplatin + etoposide
Drug: BI 764532
BI 764532
Drug: Carboplatin
Standard of care
Drug: Etoposide
Standard of care
Experimental: Part A: BI 764532 medium dose + carboplatin + etoposide
Drug: BI 764532
BI 764532
Drug: Carboplatin
Standard of care
Drug: Etoposide
Standard of care
Experimental: Part A: BI 764532 high dose + carboplatin + etoposide
Drug: BI 764532
BI 764532
Drug: Carboplatin
Standard of care
Drug: Etoposide
Standard of care
Experimental: Part B: BI 764532 + carboplatin + etoposide
Drug: BI 764532
BI 764532
Drug: Carboplatin
Standard of care
Drug: Etoposide
Standard of care
Experimental: Part B: BI 764532 + cisplatin + etoposide
Drug: BI 764532
BI 764532
Drug: Cisplatin
Standard of care
Drug: Etoposide
Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part A: Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Time Frame: Up to 21 days.
Up to 21 days.
Part B: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period
Time Frame: Up to 36 months.
Up to 36 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period
Time Frame: Up to 36 months.
Up to 36 months.
Part A: Occurrence of adverse events (AEs) during the on-treatment period
Time Frame: Up to 36 months.
Up to 36 months.
Part B: Objective response (OR)
Time Frame: Up to 36 months.
Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 (based on investigator's assessment) from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.
Up to 36 months.
Part B: Duration of response (DoR)
Time Frame: Up to 36 months.
Duration of response (DoR), defined as the time from first documented confirmed objective response (OR) until the earliest date of disease progression or death among patients with confirmed objective response.
Up to 36 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2023

Primary Completion (Estimated)

November 5, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 10, 2023

First Submitted That Met QC Criteria

November 10, 2023

First Posted (Actual)

November 15, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1438-0007
  • U1111-1292-1400 (Registry Identifier: WHO Registry)
  • 2023-505870-13-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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