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NCT06540066 · ClinicalTrials.gov registry record · Phase 1
A Study of BGB-B3227 Alone and in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors
A Phase 1 study, sponsored by BeiGene.
- Terminated
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT06540066: Clinical Trial Phase 1 study, sponsored by BeiGene.
NCT06540066 is a Phase 1 study that was terminated before completion, run by BeiGene. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06540066, a Phase 1 study, was terminated before completion, sponsored by BeiGene.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of BGB-B3227, a humanized immunoglobulin G1 (IgG1) antibody. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-B3227 as a monotherapy or in combination with tislelizumab with or without chemotherapy in participants with selected advanced or metastatic solid tumors. The study will also identify recommended dose(s) for expansion (RDFE\[s\]) of BGB-B3227 administered alone and in combination with tislelizumab.
Primary Outcome
Number of participants with AEs and SAEs, including findings from physical examinations, laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria or protocol-defined Adverse Event of Special Interest (AESI) criteria.
Interventions
- DRUG Tislelizumab
- DRUG Chemotherapy
- DRUG BGB-B3227
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2024-09-11 |
| Est. Completion | 2026-01-09 |
| Phase | Phase 1 |
Why NCT06540066 stopped before completion
NCT06540066 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 3 interventions - of which Tislelizumab is the first listed.
NCT06540066 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06540066 about?
NCT06540066 is a clinical study titled "A Study of BGB-B3227 Alone and in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors". This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of BGB-B3227, a humanized immunoglobulin G1 (IgG1) antibody. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of B...
What is the current status of trial NCT06540066?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2024-09-11. Estimated completion is 2026-01-09.
What interventions are being tested in trial NCT06540066?
The interventions under investigation include: Tislelizumab (DRUG), Chemotherapy (DRUG), BGB-B3227 (DRUG).
Who is sponsoring clinical trial NCT06540066?
This trial is sponsored by BeiGene, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06540066's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 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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