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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06132113




Registration number
NCT06132113
Ethics application status
Date submitted
10/11/2023
Date registered
15/11/2023

Titles & IDs
Public 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
Scientific 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)
Secondary ID [1] 0 0
U1111-1292-1400
Secondary ID [2] 0 0
1438-0007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroendocrine Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BI 764532
Treatment: Drugs - Carboplatin
Treatment: Drugs - Etoposide
Treatment: Drugs - Cisplatin

Experimental: Part A: BI 764532 low dose + carboplatin + etoposide -

Experimental: Part A: BI 764532 medium dose + carboplatin + etoposide -

Experimental: Part A: BI 764532 high dose + carboplatin + etoposide -

Experimental: Part B: BI 764532 + carboplatin + etoposide -

Experimental: Part B: BI 764532 + cisplatin + etoposide -


Treatment: Drugs: BI 764532
BI 764532

Treatment: Drugs: Carboplatin
Standard of care

Treatment: Drugs: Etoposide
Standard of care

Treatment: Drugs: Cisplatin
Standard of care
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A: Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Timepoint [1] 0 0
Up to 21 days.
Primary outcome [2] 0 0
Part B: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period
Timepoint [2] 0 0
Up to 36 months.
Secondary outcome [1] 0 0
Part A: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period
Timepoint [1] 0 0
Up to 36 months.
Secondary outcome [2] 0 0
Part A: Occurrence of adverse events (AEs) during the on-treatment period
Timepoint [2] 0 0
Up to 36 months.
Secondary outcome [3] 0 0
Part B: Objective response (OR)
Timepoint [3] 0 0
Up to 36 months.
Secondary outcome [4] 0 0
Part B: Duration of response (DoR)
Timepoint [4] 0 0
Up to 36 months.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
55
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles
Country [6] 0 0
Belgium
State/province [6] 0 0
Edegem
Country [7] 0 0
France
State/province [7] 0 0
Marseille
Country [8] 0 0
Germany
State/province [8] 0 0
München
Country [9] 0 0
Germany
State/province [9] 0 0
Tübingen
Country [10] 0 0
Japan
State/province [10] 0 0
Aichi, Nagoya
Country [11] 0 0
Japan
State/province [11] 0 0
Chiba, Kashiwa
Country [12] 0 0
Japan
State/province [12] 0 0
Osaka, Osaka
Country [13] 0 0
Japan
State/province [13] 0 0
Tokyo, Chuo-ku
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
Spain
State/province [15] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Boehringer Ingelheim
Address 0 0
Country 0 0
Phone 0 0
1-800-243-0127
Fax 0 0
Email 0 0
clintriage.rdg@boehringer-ingelheim.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06132113