DAREON™-7: A Study to Test How Well Different Doses of BI 764532 in Addition to Chemotherapy Are … (NCT06132113) | Clinical Trial Compass
Active — Not RecruitingPhase 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
United States, Belgium, France55 participantsStarted 2024-01-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on finding the right dose of BI 764532 combined with chemotherapy, what does that mean for what's currently known about its safety and effectiveness in people with neuroendocrine cancers like mine?
2The trial is actively enrolling but no longer recruiting — does that mean there's any chance of joining a future phase or related study, or should we focus on other options right now?
3Because the main thing being measured in this study is dose-limiting toxicities, how would my doctors monitor me for serious side effects, and what kinds of reactions have been seen so far with this drug combination?
4How does adding BI 764532 to chemotherapy compare to receiving standard chemotherapy alone for my type of neuroendocrine cancer — is there a reason to consider this experimental approach over established treatments at this stage?
5Given that this trial involves different dosing parts (Part A1, A2, and Part B), can you explain which part of the study was relevant to patients with my specific cancer, and what the monitoring demands would have looked like for my daily life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part A1: Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Timeframe: Up to 21 days.
2
Part A2: Reduced monitoring: the occurrence of DLTs during the on-treatment period
Timeframe: Up to 36 months.
3
Part B: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period