Clinical trial · Interventional
Study of Sonrotoclax (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
NCT05471843CI-TRIAL-00094798active not recruitingPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The study consists of two parts. Part 1 determines the safety and tolerability of sonrotoclax monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of sonrotoclax monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of sonrotoclax monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Refractory Mantle Cell Lymphoma (MCL) | Mantle Cell Lymphoma | CURATED_BROADER | 0.78 |
| Relapsed Mantle Cell Lymphoma | Mantle Cell Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sonrotoclax | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part 1: Sonrotoclax 160 mg (Daily Ramp-up)
- description
- Participants received sonrotoclax at the target dose of 160 mg orally once a day (QD) after an approximately 4-week ramp-up schedule starting at 1 mg with daily dose increases until the target dose was reached. Participants received sonrotoclax until disease progression, unacceptable toxicity, or consent withdrawal.
- interventionNames
- Drug: Sonrotoclax
- type
- EXPERIMENTAL
- label
- Part 1: Sonrotoclax 320 mg (Daily Ramp-up)
- description
- Participants received sonrotoclax at the target dose of 320 mg orally once a day after an approximately 4-week ramp-up schedule starting at 1 mg with daily dose increases until the target dose was reached. Participants received sonrotoclax until disease progression, unacceptable toxicity, or consent withdrawal.
- interventionNames
- Drug: Sonrotoclax
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDWang M, Schuster SJ, Phillips T, Lossos IS, Goy A, Rule S, Hamadani M, Ghosh N, Reeder CB, Barnett E, Bravo MC, Martin P. Observational study of lenalidomide in patients with mantle cell lymphoma who relapsed/progressed after or were refractory/intolerant to ibrutinib (MCL-004). J Hematol Oncol. 2017 Nov 2;10(1):171. doi: 10.1186/s13045-017-0537-5. PMID 29096668
- BACKGROUNDJain P, Romaguera J, Srour SA, Lee HJ, Hagemeister F, Westin J, Fayad L, Samaniego F, Badillo M, Zhang L, Nastoupil L, Kanagal-Shamanna R, Fowler N, Wang ML. Four-year follow-up of a single arm, phase II clinical trial of ibrutinib with rituximab (IR) in patients with relapsed/refractory mantle cell lymphoma (MCL). Br J Haematol. 2018 Aug;182(3):404-411. doi: 10.1111/bjh.15411. Epub 2018 May 22. PMID 29785709
- BACKGROUNDMartin P, Maddocks K, Leonard JP, Ruan J, Goy A, Wagner-Johnston N, Rule S, Advani R, Iberri D, Phillips T, Spurgeon S, Kozin E, Noto K, Chen Z, Jurczak W, Auer R, Chmielowska E, Stilgenbauer S, Bloehdorn J, Portell C, Williams ME, Dreyling M, Barr PM, Chen-Kiang S, DiLiberto M, Furman RR, Blum KA. Postibrutinib outcomes in patients with mantle cell lymphoma. Blood. 2016 Mar 24;127(12):1559-63. doi: 10.1182/blood-2015-10-673145. Epub 2016 Jan 13. PMID 26764355
- DERIVEDEyre 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