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
- Conditions
- Neuroendocrine Neoplasms
- Interventions
- Registration Number
- NCT06132113
- Lead Sponsor
- Boehringer Ingelheim
- 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 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
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 55
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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
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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
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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
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Minimum life expectancy of 12 weeks
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At least one measurable lesion as defined per RECIST 1.1 within approximately 35 days prior to the first dose of BI 764532
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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.
- 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
- 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 or well differentiated neuroendocrine tumour (NET) stages of the target indication in case of transformed tumors), except for appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix Further exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: BI 764532 high dose + carboplatin + etoposide BI 764532 - Part A: BI 764532 high dose + carboplatin + etoposide Carboplatin - Part A: BI 764532 high dose + carboplatin + etoposide Etoposide - Part B: BI 764532 + carboplatin + etoposide BI 764532 - Part B: BI 764532 + carboplatin + etoposide Carboplatin - Part B: BI 764532 + carboplatin + etoposide Etoposide - Part B: BI 764532 + cisplatin + etoposide BI 764532 - Part B: BI 764532 + cisplatin + etoposide Etoposide - Part B: BI 764532 + cisplatin + etoposide Cisplatin - Part A: BI 764532 low dose + carboplatin + etoposide BI 764532 - Part A: BI 764532 low dose + carboplatin + etoposide Carboplatin - Part A: BI 764532 low dose + carboplatin + etoposide Etoposide - Part A: BI 764532 medium dose + carboplatin + etoposide BI 764532 - Part A: BI 764532 medium dose + carboplatin + etoposide Carboplatin - Part A: BI 764532 medium dose + carboplatin + etoposide Etoposide -
- Primary Outcome Measures
Name Time Method Part B: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period Up to 36 months. Part A: Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period Up to 21 days.
- Secondary Outcome Measures
Name Time Method Part B: Duration of response (DoR) 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.
Part A: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period Up to 36 months. Part A: Occurrence of adverse events (AEs) during the on-treatment period Up to 36 months. Part B: Objective response (OR) 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.
Related Research Topics
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Trial Locations
- Locations (21)
University of Miami
🇺🇸Miami, Florida, United States
Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Northwestern University
🇺🇸Chicago, Illinois, United States
John Theurer Cancer Center
🇺🇸Hackensack, New Jersey, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Brussels - UNIV Saint-Luc
🇧🇪Bruxelles, Belgium
Edegem - UNIV UZ Antwerpen
🇧🇪Edegem, Belgium
HOP Louis Pradel
🇫🇷Bron, France
INS Paoli-Calmettes
🇫🇷Marseille, France
Klinikum der Universität München AÖR
🇩🇪München, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Aichi Cancer Center Hospital
🇯🇵Aichi, Nagoya, Japan
National Cancer Center Hospital East
🇯🇵Chiba, Kashiwa, Japan
Osaka International Cancer Institute
🇯🇵Osaka, Osaka, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Chuo-ku, Japan
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Sahlgrenska Universitetsjukhuset
🇸🇪Göteborg, Sweden
Akademiska hospital
🇸🇪Uppsala, Sweden