A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3
NCT ID: NCT04429087
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
300 participants
INTERVENTIONAL
2020-07-29
2027-02-15
Brief Summary
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The purpose of this study is to find out the highest dose of BI 764532 and the best treatment schedule that people can tolerate. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. In this study, BI 764532 is given to people for the first time. That means no clinical data are available for BI 764532.
Participants get BI 764532 either weekly or once every 3 weeks. If there is benefit for the participants and if they can tolerate it, the treatment is given for a maximum of 3 years. During this time, participants visit the study site about 20 times depending on the response to the treatment. Doctors record any unwanted effects and regularly check the general health of the participants.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: BI 764532
BI 764532 - parenteral 1
BI 764532 - parenteral 1
Arm 2: BI 764532
BI 764532 - parenteral 2
BI 764532 - parenteral 2
Interventions
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BI 764532 - parenteral 1
BI 764532 - parenteral 1
BI 764532 - parenteral 2
BI 764532 - parenteral 2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Locally advanced or metastatic cancer not amenable to curative treatment; of following histologies:
* Small cell lung carcinoma (SCLC)
* Large cells neuroendocrine lung carcinoma (LCNEC)
* Neuroendocrine carcinoma (NEC) or small cell carcinoma of any other origin
* Tumours must be positive for DLL3 expression (on archived tissue or instudy fresh biopsy) according to central pathology review in order to start BI 764532
* Patients with tumours with mixed histologies for any above type are eligible only if neuroendocrine carcinoma/small tumor cells component is predominant and represent at least 50% of the overall tumour tissue.
* For back-fill cohorts only: patient has agreed to and signed an IC to provide mandatory pre-treatment and on-treatment fresh tumor biopsy.
* Patient has failed or is not eligible for available standard therapies according to local guidelines. Standard therapies should include at least one line of chemotherapy that should include platinum for patients with small cells carcinoma tumors histologies.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* At least one evaluable lesion outside of CNS as defined per modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
* Subjects with brain metastases are eligible provided they meet the following criteria:
* Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 764532
* Patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant Central Nervous System (CNS) disease.
Exclusion Criteria
* Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed (e.g. biopsy).
* Persistent toxicity from previous treatments that has not resolved to = Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, CTCAE Grade 2 neuropathy, asthenia/fatigue or grade 2 endocrinopathies controlled by replacement therapy).
* Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of BI 764532. Physiological replacement of steroids is allowed.
* Prior anti-cancer therapy:
* Patients who have been treated with any other anti-cancer drug within 3 weeks or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532.
* Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532.
* Other active malignancy that could interfere with the prognosis and treatment of the disease of the study.
* Major surgery within 28 days of first dose BI 764532.
* Women who are pregnant (including those who are considered to be possibly pregnant based on the investigator's clinical judgement), nursing/breast feeding or who plan to become pregnant or nurse while in the trial or within 35 days after the last dose of study treatment.
* Active infection that requires medical therapy or other clinically significant intervention or within 2 weeks prior to study entry confirmed (PCR test or other applicable test as per local requirements) or suspected SARS-CoV-2 infection or close contact with an individual with confirmed SARS-CoV-2 infection.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Winship Cancer Institute
Atlanta, Georgia, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Universitätsklinikum Köln (AöR)
Cologne, , Germany
Technische Universität Dresden
Dresden, , Germany
Universitätsklinikum Würzburg AÖR
Würzburg, , Germany
National Cancer Center Hospital East
Chiba, Kashiwa, , Japan
Hospital del Mar
Barcelona, , Spain
Hospital Universitari Vall D Hebron
Barcelona, , Spain
Clínica Universidad de Navarra
Pamplona, , Spain
Hospital Clinico Universitario De Valencia
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Wermke M, Felip E, Gambardella V, Kuboki Y, Morgensztern D, Hamed ZO, Liu M, Studeny M, Owonikoko TK. Phase I trial of the DLL3/CD3 bispecific T-cell engager BI 764532 in DLL3-positive small-cell lung cancer and neuroendocrine carcinomas. Future Oncol. 2022 Aug;18(24):2639-2649. doi: 10.2217/fon-2022-0196. Epub 2022 Jul 11.
Related Links
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Related Info
Other Identifiers
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2019-000729-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1438-0001
Identifier Type: -
Identifier Source: org_study_id
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