Testing BI 764532 with chemotherapy for advanced neuroendocrine cancers
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 testing a new drug called BI 764532 combined with chemotherapy to see if it helps adults with advanced neuroendocrine cancers that have a specific marker called DLL3.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boehringer Ingelheim Industry-sponsored |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 20 sites (Miami, Florida and 19 other locations) |
| Trial ID | NCT06132113 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and tolerability of BI 764532 in combination with chemotherapy for adults with advanced neuroendocrine cancers that express the DLL3 marker. The study is divided into two parts: the first part determines the maximum tolerated dose of BI 764532 alongside chemotherapy, while the second part assesses its tolerability with various chemotherapy regimens. Participants will receive infusions of BI 764532 and platinum-based chemotherapy, with the possibility of treatment continuation for up to three years if they benefit and can tolerate the regimen. Regular doctor visits will monitor their health and treatment response.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced neuroendocrine cancers that are positive for the DLL3 marker.
Not a fit: Patients with neuroendocrine cancers that do not express the DLL3 marker or those with a poor performance status may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced neuroendocrine cancers.
How similar studies have performed: While this approach is novel in the context of combining BI 764532 with chemotherapy for neuroendocrine cancers, similar studies have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 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.
Where this trial is running
Miami, Florida and 19 other locations
- University of Miami — Miami, Florida, United States (Recruiting)
- Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Not_yet_recruiting)
- John Theurer Cancer Center — Hackensack, New Jersey, United States (Recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Cliniques Universitaires Saint-Luc — Brussels, Belgium (Recruiting)
- Hôpital Louis Pradel — Bron, France (Not_yet_recruiting)
- INS Paoli-Calmettes — Marseille, France (Recruiting)
- Klinikum der Universität München AÖR — München, Germany (Not_yet_recruiting)
- Universitätsklinikum Tübingen — Tübingen, Germany (Recruiting)
- Aichi Cancer Center Hospital — Aichi, Nagoya, Japan (Recruiting)
- National Cancer Center Hospital East — Chiba, Kashiwa, Japan (Recruiting)
- Osaka International Cancer Institute — Osaka, Osaka, Japan (Recruiting)
- National Cancer Center Hospital — Tokyo, Chuo-ku, Japan (Recruiting)
- Universitair Medisch Centrum Groningen — Groningen, Netherlands (Recruiting)
- Hospital Universitari Vall d'Hebron — Barcelona, Spain (Recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
- Hospital Universitario La Paz — Madrid, Spain (Recruiting)
- Sahlgrenska Universitetsjukhuset — Gothenburg, Sweden (Recruiting)
- Uppsala University Hospital — Uppsala, Sweden (Not_yet_recruiting)
Study contacts
- Study coordinator: Boehringer Ingelheim
- Email: clintriage.rdg@boehringer-ingelheim.com
- Phone: 1-800-243-0127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.