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NCT04180371 · ClinicalTrials.gov registry record · Phase 1
Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression
A Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, sponsored by BicycleTx Limited.
- Active
- Registry status
- Phase 1
- Development phase
- 288
- Enrollment target
- 20
- Study locations
NCT04180371: Active Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, sponsored by BicycleTx Limited.
NCT04180371 is a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer that is active but no longer recruiting, run by BicycleTx Limited. The registered enrollment target is 288 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04180371, a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, is active but no longer recruiting, sponsored by BicycleTx Limited.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 288 participants
- Enrollment target
- 20
- Study locations
Study Summary
This clinical trial is evaluating a drug called BT5528 alone and in combination with nivolumab in participants with advanced solid tumors historically known for expression of EphA2. The main goals of this study are to: * Find the recommended dose(s) of BT5528 that can be given safely to participants alone and in combination with nivolumab * Learn more about the side effects of BT5528 * Learn about how effective BT5528 is for the treatment of ovarian cancer, urothelial/bladder cancer, lung cancer (NSCLC), triple-negative breast cancer, head and neck cancer (HNSCC), and gastric/upper gastrointestinal cancer. * Learn more about BT5528 therapy alone and in combination with nivolumab.
Primary Outcome
Safety reported as incidence of treatment-emergent adverse events
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG BT5528
Study Locations (20)
Other
- Institut Jules Bordet - Brussels
- Cliniques Universitaires Saint-Luc - Brussels
- Antwerp University Hospital (UZA) - Edegem
- Universitair Ziekenhuis Gent (UZ) - Ghent
- Gachon University Gil Medical Center - Incheon
- Severance Hospital, Yonsei University Health System - Seoul
- Institut Catala d'Oncologia - L'Hospitalet - Barcelona
- Hospital Universitario Vall d'Hebron - Barcelona
California
- California Cancer Associates for Research and Excellence, Inc. - Encinitas
- University of California - Irvine Medical Center - Orange
Colorado
- Sarah Cannon Research Institute at HealthONE - Denver
Florida
- Florida Cancer Specialists - Sarasota
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit
Nevada
- Comprehensive Cancer Centers of Nevada - Las Vegas
New York
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center - New York
Oklahoma
- Stephenson Cancer Center (Oklahoma University) - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2019-11-07 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 1 |
What the registry record for NCT04180371 still lists
NCT04180371 is an interventional study that assigns participants to a tested intervention. The registered 288 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (56% lower).
The record links to 7 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT04180371 names 20 study sites across 12 states, led by Other, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT04180371 about?
NCT04180371 is a clinical study titled "Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression". This clinical trial is evaluating a drug called BT5528 alone and in combination with nivolumab in participants with advanced solid tumors historically known for expression of EphA2. The main goals of this study are to: * Find the recommended dose(s) of BT5528 that can be given safely to participant...
What is the current status of trial NCT04180371?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 288 participants. The study started on 2019-11-07. Estimated completion is 2027-07-31.
What conditions does trial NCT04180371 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Ovarian Cancer, Head and Neck Cancer, Triple Negative Breast Cancer, Urothelial Cancer.
What interventions are being tested in trial NCT04180371?
The interventions under investigation include: Nivolumab (DRUG), BT5528 (DRUG).
Who is sponsoring clinical trial NCT04180371?
This trial is sponsored by BicycleTx Limited, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04180371 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Michigan, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-Small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04180371's enrollment target sits among peer trials
288 130th of 454 higher than 325 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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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