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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

Status
Active
Cancer Type
Neuroendocrine Tumor
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06132113
Protocol IDs
1438-0007 (primary)
NCI-2024-00432
2023-505870-13-00
U1111-1292-1400
Study Sponsor
Boehringer Ingelheim Pharmaceuticals Inc

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.

Eligibility

  1. 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)
  2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses
  3. Patients diagnosed with locally advanced or metastatic NEC of following subtypes:
  4. extrapulmonary neuroendocrine carcinomas (epNEC)
  5. pulmonary large cell NEC (LCNEC)
  6. neuroendocrine carcinomas (NEC) of unknown primary site
  7. 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
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  9. Minimum life expectancy of 12 weeks
  10. At least one measurable lesion as defined per RECIST 1.1 within 35 days prior to the first dose of BI 764532
  11. Patients with a history of asymptomatic Central nervous system (CNS) metastases are eligible, provided they meet all of the following criteria:
  12. No radiotherapy (including whole brain radiation therapy, stereotactic radiotherapy or radiosurgery) within 7 days
  13. 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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.