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

Neuroendocrine Neoplasms Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06132113
• Other study ID #: 1438-0007
• Secondary ID: U1111-1292-14002
• Status: Recruiting
• Phase: Phase 1
• Start date: December 20, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 1, 2025
• Est. primary completion date: November 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuroendocrine Neoplasms
• Neuroendocrine Tumors

Intervention

Drug:
• BI 764532
BI 764532
• Carboplatin
Standard of care
• Etoposide
Standard of care
• Cisplatin
Standard of care

Locations

Country	Name	City	State
Germany	Universitätsklinikum Tübingen	Tübingen
Japan	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
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital La Paz	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Germany,  Japan,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period		Up to 21 days.
Primary	Part B: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period		Up to 36 months.
Secondary	Part A: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period		Up to 36 months.
Secondary	Part A: Occurrence of adverse events (AEs) during the on-treatment period		Up to 36 months.
Secondary	Part B: Objective response (OR)	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.
Secondary	Part B: Duration of response (DoR)	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.

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