TriangleNCT05471843 · CITED IN SOURCE DOCUMENTS
Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE1, PHASE2
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2025-09-09
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- Key Inclusion Criteria: 1. Histologically confirmed diagnosis of MCL 2. Prior systemic treatments for MCL (at least one line of anti-cluster of differentiation 20 (anti-CD20) based immune or chemoimmunotherapy and at least one kind of covalent or non-covalent adequate Bruton Tyrosine Kinase (BTK) inhibitor). 3. Relapsed/refractory disease 4. Presence of measurable disease 5. Availability of archival tissue confirming diagnosis of MCL, or willing to undergo fresh tumor biopsy 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2. 7. Adequate organ function Key Exclusion Criteria: 1. Known central nervous system involvement by lymphoma 2. Prior malignancy other than MCL within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer. 3. Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199). 4. Prior autologous stem cell transplant within the last 3 months; or prior autologous chimeric antigen receptor T-cell therapy within the last 3 months; or prior allogeneic stem cell transplant within the last 6 months or currently has an active graft-vs-host disease requiring the use of immunosuppressants. 5. Clinically significant cardiovascular disease. 6. Major surgery or significant injury ≤ 4 weeks prior to start of study treatment. 7. Active fungal, bacterial or viral infection requiring systemic treatment. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants will receive sonrotoclax
- intervention Names
- Drug: BGB-11417
- label
- Single Arm
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Single Arm
- description
- Administered orally
- name
- BGB-11417
- other Names
- sonrotoclax
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 125
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)
- time Frame
- Up to 1 Year
- measure
- Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation.
- time Frame
- Up to 5 Years
- measure
- Part 1: Number of participants experiencing tumor lysis syndrome (TLS) relevant events
- time Frame
- Up to 5 Years
- description
- Defined as the proportion of participants who achieved a complete response (CR), or partial response (PR) per the Lugano Classification
- measure
- Part 2: Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC)
- time Frame
- Up to 4 Years
- secondary Outcomes
- measure
- Part 1: Single Dose Area Under the Plasma Concentration Time Curve (AUC)
- time Frame
- Up to 2 Years
- measure
- Part 1: Single Dose Maximum Observed Plasma Concentration (Cmax)
- time Frame
- Up to 2 Years
- measure
- Part 1: Single Dose Time to reach Cmax (Tmax)
- time Frame
- Up to 2 Years
- measure
- Part 1: Steady State Area Under the Plasma Concentration Time Curve (AUC)
- time Frame
- Up to 2 Years
- measure
- Part 1: Steady State Maximum Observed Plasma Concentration (Cmax)
- time Frame
- Up to 2 Years
- measure
- Part 1: Steady State Trough Plasma Concentration (CTrough)
- time Frame
- Up to 2 Years
- measure
- Part 1: Steady State Time to reach Cmax (Tmax)
- time Frame
- Up to 2 Years
- description
- Defined as the proportion of participants who achieved a complete response (CR), or partial response (PR) per Lugano classification
- measure
- Overall Response Rate (ORR) as assessed by investigator
- time Frame
- Up to 4 Years
- description
- DOR is defined as the time from the date of the first documented response (PR or better) after treatment initiation until the date of first documented disease progression or death due to any cause; whichever occurs first
- measure
- Duration of Response (DOR) as assessed by investigator and IRC
- time Frame
- Up to 4 Years
- description
- PFS is defined as the time from the date of the first study dose until the date of first documented disease progression or death due to any cause, whichever occurs first.
- measure
- Progression Free Survival (PFS) as assessed by investigator and IRC
- time Frame
- Up to 4 Years
- description
- TTR is defined as the time from start of treatment to first documentation of response of Partial Response (PR) or better
- measure
- Time to Response (TTR) as assessed by investigator and IRC
- time Frame
- Up to 4 Years
- description
- Defined as time from the start of treatment to the date of death due to any cause
- measure
- Overall Survival (OS)
- time Frame
- Up to 4 Years
Full study description
- brief 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.
Source references
- references
- citation
- Eyre TA, Song Y, Hermine O, Shuang Y, Jurczak W, Farias JS, Mahuad C, Ozcan M, Jachimowicz RD, Chen T, Ivanova E, Li X, Man G, Bourquelot P, Vezan R, Wang M. Phase I/II Study of Sonrotoclax (BGB-11417) Monotherapy in Patients With Mantle Cell Lymphoma Previously Treated With Anti-CD20 Therapy and a Bruton Tyrosine Kinase Inhibitor. J Clin Oncol. 2026 Jul 1:JCO2600550. doi: 10.1200/JCO-26-00550. Online ahead of print.
- pmid
- 42385124
- type
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- ttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm">Drugs@FDA</a> . </p><h2>Efficacy and Safety</h2><p>Efficacy was evaluated in BGB-11417-201 (NCT05471843), a single-arm, multicenter trial in 103 adults with relapsed or refractory MCL who previously received anti-CD20-based therapy and a BTK inhibitor. </p><
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- Cell Lymphoma The safety of BEQALZI was evaluated in 115 adult patients with previously treated MCL in a single-arm, multicenter clinical trial, BGB-11417-201 (NCT05471843) [see Clinical Studies (14.1) ] . The trial required prior receipt of anti-CD20–based therapy and a BTK inhibitor. The trial excluded patients on moderate or s
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- 14 CLINICAL STUDIES 14.1 Mantle Cell Lymphoma The efficacy of BEQALZI was evaluated in a single-arm, multicenter clinical trial, BGB-11417-201 (NCT05471843). Efficacy was based on 103 adults with relapsed or refractory MCL who previously received anti-CD20–based therapy and a BTK inhibitor. The trial required an A
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Preserved source evidence · Not medical advice