drugset / Trial / NCT05471843
Study of Sonrotoclax (BGB-11417) Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2022-09-05
- Primary completion
- 2025-07-18
- Completion
- 2027-01-31
Outcome
Met primary endpoint
paper the ORR-IRC was 52.4% (95% CI, 42.4 to 62.4), a statistically significant increase versus the historic control ORR (30%; P < .0001) PMID 42385124 ↗
release “Sonrotoclax achieved its primary endpoint of overall response rate (ORR) as assessed by an independent review committee (IRC)” beonemedicines.com ↗
Publications
- Background Wang 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.
- Background Jain 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.
- Background Martin 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sonrotoclax | Other / unclassified | 160 mg | Oral |
| Subject | Sonrotoclax | Other / unclassified | 320 mg | Oral |