Trials / Active Not Recruiting
Active Not RecruitingNCT05471843
Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
A Single-Arm, Open-Label, Multicenter Phase 1/2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BCL2 Inhibitor BGB-11417 in Patients With Relapsed or Refractory Mantle Cell Lymphoma
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 125 (actual)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BGB-11417 | Administered orally |
Timeline
- Start date
- 2022-09-05
- Primary completion
- 2025-07-18
- Completion
- 2027-01-31
- First posted
- 2022-07-25
- Last updated
- 2025-09-09
Locations
104 sites across 15 countries: United States, Argentina, Belgium, Brazil, Canada, China, France, Germany, Israel, Italy, Poland, Puerto Rico, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05471843. Inclusion in this directory is not an endorsement.