Clinical Trials/NCT06132113

NCT06132113

Recruiting

Phase 1

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)

Boehringer Ingelheim38 sites in 8 countries55 target enrollmentJanuary 22, 2024

ConditionsNeuroendocrine Neoplasms

InterventionsEtoposide BI 764532 Carboplatin Cisplatin

DrugsBI 764532 Carboplatin Etoposide Cisplatin

Overview

Phase: Phase 1
Intervention: Etoposide
Conditions: Neuroendocrine Neoplasms
Sponsor: Boehringer Ingelheim
Enrollment: 55
Locations: 38
Primary Endpoint: Part A1: Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Status: Recruiting
Last Updated: 2 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

January 22, 2024

End Date

April 25, 2027

Last Updated

2 days ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility 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

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.

Intervention: Carboplatin

Outcomes

Primary Outcomes

Part A1: Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period

Time Frame: Up to 21 days.

Part A2: Reduced monitoring: the occurrence of DLTs during the on-treatment period

Time Frame: Up to 36 months.

Part B: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period

Time Frame: Up to 36 months.

Part A1: Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period

Time Frame: Up to 21 days.

Part A2: Reduced monitoring: the occurrence of DLTs during the on-treatment period

Time Frame: Up to 36 months.

Part B: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period

Time Frame: Up to 36 months.

Secondary Outcomes

Part A1: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period(Up to 36 months.)
Part A1: Occurrence of adverse events (AEs) during the on-treatment period(Up to 36 months.)
Part A2: Occurrence of adverse events (AEs) during the on-treatment period(Up to 36 months.)
Part B: Duration of response (DoR)(Up to 36 months.)
Part A1: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period(Up to 36 months.)
Part A1: Occurrence of adverse events (AEs) during the on-treatment period(Up to 36 months.)
Part A2: Occurrence of adverse events (AEs) during the on-treatment period(Up to 36 months.)
Part A2: Objective response (OR)(Up to 36 months.)
Part B: Objective response (OR)(Up to 36 months.)
Part B: Duration of response (DoR)(Up to 36 months.)