Trial Title:
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
NCT ID:
NCT06132113
Condition:
Neuroendocrine Neoplasms
Conditions: Official terms:
Neuroendocrine Tumors
Carboplatin
Etoposide
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Part A: Dose escalation, Part B: Dose expansion
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BI 764532
Description:
BI 764532
Arm group label:
Part A: BI 764532 high dose + carboplatin + etoposide
Arm group label:
Part A: BI 764532 low dose + carboplatin + etoposide
Arm group label:
Part A: BI 764532 medium dose + carboplatin + etoposide
Arm group label:
Part B: BI 764532 + carboplatin + etoposide
Arm group label:
Part B: BI 764532 + cisplatin + etoposide
Other name:
Obrixtamig
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Standard of care
Arm group label:
Part A: BI 764532 high dose + carboplatin + etoposide
Arm group label:
Part A: BI 764532 low dose + carboplatin + etoposide
Arm group label:
Part A: BI 764532 medium dose + carboplatin + etoposide
Arm group label:
Part B: BI 764532 + carboplatin + etoposide
Intervention type:
Drug
Intervention name:
Etoposide
Description:
Standard of care
Arm group label:
Part A: BI 764532 high dose + carboplatin + etoposide
Arm group label:
Part A: BI 764532 low dose + carboplatin + etoposide
Arm group label:
Part A: BI 764532 medium dose + carboplatin + etoposide
Arm group label:
Part B: BI 764532 + carboplatin + etoposide
Arm group label:
Part B: BI 764532 + cisplatin + etoposide
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Standard of care
Arm group label:
Part B: BI 764532 + cisplatin + etoposide
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.
Criteria for 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 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
John Theurer Cancer Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
University of Pittsburgh Medical Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Brussels - UNIV Saint-Luc
Address:
City:
Bruxelles
Zip:
1200
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
080049616
Email:
belgique@bitrialsupport.com
Facility:
Name:
Edegem - UNIV UZ Antwerpen
Address:
City:
Edegem
Zip:
2650
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
080049616
Email:
belgique@bitrialsupport.com
Facility:
Name:
INS Paoli-Calmettes
Address:
City:
Marseille
Zip:
13273
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
Klinikum der Universität München AÖR
Address:
City:
München
Zip:
81377
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Universitätsklinikum Tübingen
Address:
City:
Tübingen
Zip:
72076
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Aichi Cancer Center Hospital
Address:
City:
Aichi, Nagoya
Zip:
464-8681
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Chiba, Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Osaka International Cancer Institute
Address:
City:
Osaka, Osaka
Zip:
541-8567
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Tokyo, Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Hospital Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Hospital La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Start date:
December 20, 2023
Completion date:
August 10, 2026
Lead sponsor:
Agency:
Boehringer Ingelheim
Agency class:
Industry
Source:
Boehringer Ingelheim
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06132113
https://www.mystudywindow.com
