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NCT04429087 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Patients With Small Cell Lung Carcinoma and Other Neoplasms, sponsored by Boehringer Ingelheim.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 300
- Enrollment target
- 12
- Study locations
NCT04429087: Recruiting Phase 1 study of Patients With Small Cell Lung Carcinoma and Other Neoplasms, sponsored by Boehringer Ingelheim.
NCT04429087 is a Phase 1 study of Patients With Small Cell Lung Carcinoma and Other Neoplasms that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 300 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (400% higher). The trial reports 12 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04429087, a Phase 1 study of Patients With Small Cell Lung Carcinoma and Other Neoplasms, is actively recruiting participants, sponsored by Boehringer Ingelheim.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 300 participants
- Enrollment target
- 12
- Study locations
Study Summary
This study is open to adults with small cell lung cancer and other neuroendocrine cancers that are positive for the tumour marker delta-like 3 (DLL3). The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. 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.
Primary Outcome
Maximum tolerated dose (MTD) in any studied regimen defined as the highest dose with less than 25% risk of the true Dose Limiting Toxicity (DLT) rate being equal or above 33% during the MTD evaluation period. Separate MTDs will be determined for each Regimen.
Conditions Studied
Interventions
- DRUG BI 764532 - parenteral 1
- DRUG BI 764532 - parenteral 2
Study Locations (12)
Other
- Universitätsklinikum Köln (AöR) - Cologne
- Technische Universität Dresden - Dresden
- Universitätsklinikum Würzburg AÖR - Würzburg
- National Cancer Center Hospital East - Chiba, Kashiwa
- Hospital del Mar - Barcelona
- Hospital Universitari Vall D Hebron - Barcelona
- Clínica Universidad de Navarra - Pamplona
- Hospital Clinico Universitario De Valencia - Valencia
Georgia
- Winship Cancer Institute - Atlanta
Maryland
- University of Maryland School of Medicine - Baltimore
Missouri
- Washington University School of Medicine - St Louis
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2020-07-29 |
| Est. Completion | 2027-02-15 |
| Phase | Phase 1 |
What NCT04429087 shows while recruiting
NCT04429087 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (400% higher).
The record links to 1 condition, with Patients With Small Cell Lung Carcinoma and Other Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which BI 764532 - parenteral 1 is the first listed.
NCT04429087 lists 12 locations in 5 states (Other, Georgia, Maryland).
Frequently Asked Questions
What is clinical trial NCT04429087 about?
NCT04429087 is a clinical study titled "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". This study is open to adults with small cell lung cancer and other neuroendocrine cancers that are positive for the tumour marker delta-like 3 (DLL3). The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this stud...
What is the current status of trial NCT04429087?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 300 participants. The study started on 2020-07-29. Estimated completion is 2027-02-15.
What conditions does trial NCT04429087 study?
This clinical trial studies the following conditions: Patients With Small Cell Lung Carcinoma and Other Neoplasms.
What interventions are being tested in trial NCT04429087?
The interventions under investigation include: BI 764532 - parenteral 1 (DRUG), BI 764532 - parenteral 2 (DRUG).
Who is sponsoring clinical trial NCT04429087?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04429087 being conducted?
This trial has 12 study locations across Georgia, Maryland, Missouri, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04429087's enrollment target sits among peer trials
300 124th of 2000 higher than 1,868 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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