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NCT04958239 · ClinicalTrials.gov registry record · Phase 1
A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer
A Phase 1 study of Neoplasms, sponsored by Boehringer Ingelheim.
- Active
- Registry status
- Phase 1
- Development phase
- 151
- Enrollment target
- 20
- Study locations
NCT04958239: Active Phase 1 study of Neoplasms, sponsored by Boehringer Ingelheim.
NCT04958239 is a Phase 1 study of Neoplasms that is active but no longer recruiting, run by Boehringer Ingelheim. The registered enrollment target is 151 participants, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04958239, a Phase 1 study of Neoplasms, is active but no longer recruiting, sponsored by Boehringer Ingelheim.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 151 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is open to adults with advanced cancer (solid tumors) and people with advanced head and neck cancer. The study has 2 parts. The purpose of Part 1 of this study is to find the highest dose of a medicine called BI 765179 that people with solid tumors can tolerate when taken alone or together with a medicine called ezabenlimab. The goal of Part 2 is to find out whether BI 765179 in combination with a medicine called pembrolizumab helps people with advanced head and neck cancer. In Part 1, each participant is put into 1 of 2 groups. Participants get BI 765179 alone or in combination with ezabenlimab as infusion into a vein every 3 weeks. In Part 2, participants are also divided into 2 groups. 1 group gets a low dose of BI 765179 in combination with pembrolizumab and the other group gets a high dose of BI 765179 in combination with pembrolizumab. Participants receive the study treatment as infusions into a vein. BI 765179, ezabenlimab, and pembrolizumab are antibodies that may help the immune system fight cancer. In this study, BI 765179 is given to people for the first time. Participants can stay in the study up to 2 years if they benefit from treatment and can tolerate it. The doctors regularly check the participants' health and note any health problems that could have been caused by the study treatment.
Primary Outcome
MTD is defined as the highest dose with less than 25% risk of the true Dose Limiting Toxicity (DLT) rate being equal to or above 33% during the MTD evaluation period. The MTD will be assessed based on the number of patients experiencing DLTs, graded according to Common terminology criteria for adverse events (CTCAE) version 5.0, during the MTD evaluation period.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Ezabenlimab
- DRUG BI 765179
Study Locations (20)
Other
- Cliniques Universitaires Saint-Luc - Brussels
- Edegem - UNIV UZ Antwerpen - Edegem
- AZ Groeninge - Kortrijk
- ICESP - Instituto do Cancer do Estado de Sao Paulo - São Paulo
- Hospital Sírio Libanês-São Paulo-68088 - São Paulo
- Beneficência Portuguesa - Real e Benemérita Associação Portuguesa de Beneficência - São Paulo
- The First Affiliated Hospital Of Bengbu Medical College - Bengbu
- Hunan Province Tumor Hospital - Changsha
- Fujian Cancer Hospital - Fuzhou
- Affiliated Cancer Hospital and Institute of Guangzhou Medical University - Guangzhou
- Wuhan Union Hospital - Wuhan
New South Wales
- Border Cancer Hospital - Albury
- Kinghorn Cancer Centre - Darlinghurst
Arizona
- University of Arizona - Tucson
California
- Beverly Hills Cancer Center - Beverly Hills
North Carolina
- The University of North Carolina at Chapel Hill - Chapel Hill
South Dakota
- Avera Cancer Institute - Sioux Falls
Texas
- NEXT Oncology-San Antonio-65273 - San Antonio
Queensland
- Townsville Hospital - Douglas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2021-10-18 |
| Est. Completion | 2028-02-17 |
| Phase | Phase 1 |
What the registry record for NCT04958239 still lists
NCT04958239 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04958239 names 20 study sites across 9 states, led by Other, New South Wales, Arizona.
Frequently Asked Questions
What is clinical trial NCT04958239 about?
NCT04958239 is a clinical study titled "A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer". This study is open to adults with advanced cancer (solid tumors) and people with advanced head and neck cancer. The study has 2 parts. The purpose of Part 1 of this study is to find the highest dose of a medicine called BI 765179 that people with solid tumors can tolerate when taken alone or togethe...
What is the current status of trial NCT04958239?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 151 participants. The study started on 2021-10-18. Estimated completion is 2028-02-17.
What conditions does trial NCT04958239 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT04958239?
The interventions under investigation include: Pembrolizumab (DRUG), Ezabenlimab (DRUG), BI 765179 (DRUG).
Who is sponsoring clinical trial NCT04958239?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04958239 being conducted?
This trial has 20 study locations across Arizona, California, North Carolina, South Dakota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04958239's enrollment target sits among peer trials
151 57th of 158 higher than 102 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms 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.
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