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NCT05006716 · ClinicalTrials.gov registry record · Phase 1
A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
A Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma, sponsored by BeOne Medicines.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 614
- Enrollment target
- 20
- Study locations
NCT05006716: Recruiting Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma, sponsored by BeOne Medicines.
NCT05006716 is a Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma that is actively recruiting participants, run by BeOne Medicines. The registered enrollment target is 614 participants, above the 179-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (243% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05006716, a Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma, is actively recruiting participants, sponsored by BeOne Medicines.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 614 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)
Primary Outcome
Number of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) including results from laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicities (DLTs); as graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
Conditions Studied
Interventions
- DRUG BGB-16673
Study Locations (20)
Arizona
- Mayo Clinic Phoenix - Phoenix
- Honor Health Research Institute - Scottsdale
- University of Arizona Cancer Center - Tucson
California
- University of California San Diego (Ucsd) Moores Cancer Center - La Jolla
- Stanford Medicine - Palo Alto
- UCLA Santa Monica Cancer Care - Santa Monica
Florida
- Mayo Clinic Jacksonville - Jacksonville
- Mount Sinai Comprehensive Cancer Center - Miami Beach
- Tampa General Hospital Cancer Institute - Tampa
Georgia
- Augusta University - Augusta
- Southeastern Regional Medical Center - Newnan
Alabama
- University of Alabama At Birmingham Hospital - Birmingham
Colorado
- Uchealth North - Fort Collins
Illinois
- Midwestern Regional Medical Center - Zion
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 614 participants |
| Start Date | 2021-09-13 |
| Est. Completion | 2029-11 |
| Phase | Phase 1 |
What NCT05006716 shows while recruiting
NCT05006716 is an interventional study that assigns participants to a tested intervention. The registered 614 participants enrollment target is mid-sized for trials with a published cap, above the 179-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (243% higher).
The record links to 9 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which BGB-16673 is the first listed.
NCT05006716 names 20 study sites across 13 states, led by Arizona, California, Florida.
Frequently Asked Questions
What is clinical trial NCT05006716 about?
NCT05006716 is a clinical study titled "A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies". Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)
What is the current status of trial NCT05006716?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 614 participants. The study started on 2021-09-13. Estimated completion is 2029-11.
What conditions does trial NCT05006716 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Non-Hodgkin Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma.
What interventions are being tested in trial NCT05006716?
The interventions under investigation include: BGB-16673 (DRUG).
Who is sponsoring clinical trial NCT05006716?
This trial is sponsored by BeOne Medicines, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05006716 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia
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 NCT05006716's enrollment target sits among peer trials
614 13th of 187 higher than 175 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia 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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