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Neuroendocrine NeoplasmsPhase 1NCT06132113

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

A Phase 1 study testing BI 764532, Carboplatin and Etoposide in people with Neuroendocrine Neoplasms, run by Boehringer Ingelheim at 21 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Neoplasms
What is being tested?
BI 764532, Carboplatin and Etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
21 sitesin 8 countries
Study dates
22 Jan 2024to 31 Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

21 sites in 8 countries.

21 sites in 8 countries

United States5 sites

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Northwestern University

    Chicago, Illinois, 60611

  • John Theurer Cancer Center

    Hackensack, New Jersey, 07601

  • University of Miami

    Miami, Florida, 33136

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

Japan4 sites

  • Aichi Cancer Center Hospital

    Aichi, Nagoya, 464-8681

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045

Other trials in Japan

Spain3 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

Other trials in Spain

Belgium2 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

Other trials in Belgium

France2 sites

  • Hopital Louis Pradel

    Bron, 69500

  • INS Paoli-Calmettes

    Marseille, 13009

Other trials in France

Germany2 sites

  • Klinikum der Universität München AÖR

    München, 81377

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

Sweden2 sites

  • Sahlgrenska Universitetsjukhuset

    Gothenburg, 413 46

  • Uppsala University Hospital

    Uppsala, 751 85

Other trials in Sweden

Netherlands1 site

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

Other trials in Netherlands

About this study

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)

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.

Read more

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.

Being tested
BI 764532, Carboplatin, Etoposide, Cisplatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06132113
Study groupRoleWhat they receive
Part A1: BI 764532 low dose + carboplatin + etoposideExperimentalNot described
Receives: Drug: BI 764532; Drug: Carboplatin; Drug: Etoposide
Part A1: BI 764532 medium dose + carboplatin + etoposideExperimentalNot described
Receives: Drug: BI 764532; Drug: Carboplatin; Drug: Etoposide
Part A1: BI 764532 high dose + carboplatin + etoposideExperimentalNot described
Receives: Drug: BI 764532; Drug: Carboplatin; Drug: Etoposide
Part B: BI 764532 + carboplatin + etoposideExperimentalNot described
Receives: Drug: BI 764532; Drug: Carboplatin; Drug: Etoposide
Part B: BI 764532 + cisplatin + etoposideExperimentalNot described
Receives: Drug: BI 764532; Drug: Etoposide; Drug: Cisplatin
Part A2: BI 764532 + carboplatin + etoposideExperimentalNot described
Receives: Drug: BI 764532; Drug: Carboplatin; Drug: Etoposide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 21 days.

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

    Measured: Up to 36 months.

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

    Measured: Up to 36 months.

Secondary outcomes (6)

  1. Part A1: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period

    Measured: Up to 36 months.

  2. Part A1: Occurrence of adverse events (AEs) during the on-treatment period

    Measured: Up to 36 months.

  3. 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.

    Measured: Up to 36 months.

  4. Part B: Duration of response (DoR)

    Duration of response (DoR), defined as the time from first documented confirmed objective response (OR) according to RECIST 1.1 (based on investigator's assessment) until the earliest date of disease progression or death among participants with confirmed objective response OR

    Measured: Up to 36 months.

  5. Part A2: Occurrence of adverse events (AEs) during the on-treatment period

    Measured: Up to 36 months.

  6. Part A2: 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.

    Measured: Up to 36 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2023
  2. Study start22 Jan 2024
  3. Primary completion9 Oct 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Part A1: Dose escalation, Part A2: Reduced monitoring, Part B: Dose expansion
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06132113
Sponsor's protocol ID
1438-0007
Other IDs
U1111-1292-1400, 2023-505870-13-00, 2023
Status last verified
Oct 2026
First submitted
10 Nov 2023
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 764532, Carboplatin and Etoposide in people with Neuroendocrine Neoplasms, run by Boehringer Ingelheim at 21 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Japan, Spain, Belgium, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A1: Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period (time frame: Up to 21 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06132113.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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