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更新于：2026-10-02
Sonrotoclax
索托克拉
更新于：2026-10-02
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、加速批准 (美国)、孤儿药 (美国)、优先审评 (美国)、附条件批准 (中国)、优先审评 (中国)、突破性疗法 (美国) |
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结构/序列
分子式C49H59N7O7S |
InChIKeyZQTKOYMWCCSKON-XKXNWSITSA-N |
CAS号2383086-06-2 |
关联
51
项与 索托克拉 相关的临床试验NCT07812246
Phase 2 Study of Fixed-Duration Zanubrutinib and Sonrotoclax (Z+S) All-Oral Combination Therapy in CLL/SLL Patients in 1st Relapse After Initial Fixed-Duration Novel Therapy (ZeuS-2 Trial)
NCT07674810
A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia
NCT07770698
A Phase 1/2a, Open-Label, Dose Finding and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sonrotoclax (BGB-11417) in Combination With Other Agents in Pediatric Patients Aged 6 Months to 17 Years, With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
100 项与 索托克拉 相关的临床结果
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100 项与 索托克拉 相关的转化医学
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100 项与 索托克拉 相关的专利（医药）
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19
项与 索托克拉 相关的文献（医药）2026-08-10JOURNAL OF CLINICAL ONCOLOGY
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
Article
作者: Wang, Michael ; Bourquelot, Priscille ; Ivanova, Elena ; Mahuad, Carolina ; Man, Gabriel ; Jachimowicz, Ron D. ; Chen, Tianlei ; Li, Xiaotong ; Hermine, Olivier ; Shuang, Yuerong ; Özcan, Muhit ; Eyre, Toby A. ; Jurczak, Wojciech ; Song, Yuqin ; Vezan, Remus ; Farias, João Samuel
PURPOSE:
Mantle cell lymphoma (MCL) is a rare and typically aggressive B-cell non-Hodgkin lymphoma characterized by recurrent relapse after short remissions. Sonrotoclax (BGB-11417) is a next-generation B-cell lymphoma 2 inhibitor with greater selectivity and potency than venetoclax, a shorter half-life, and no drug accumulation. Sonrotoclax monotherapy was evaluated in Bruton tyrosine kinase inhibitor–pretreated patients with relapsed/refractory (R/R) MCL.
METHODS:
BGB-11417-201 (ClinicalTrials.gov identifier:
NCT05471843
) is an ongoing global, open-label, phase I/II trial. Sonrotoclax was orally administered once daily with gradual, 4-week ramp-up to 160 mg or 320 mg to mitigate tumor lysis syndrome (TLS). The primary end point was overall response rate by the independent review committee (ORR-IRC) per Lugano classification; secondary end points included duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.
RESULTS:
Overall, 125 patients were enrolled and assigned to receive sonrotoclax 160 mg (n = 10) or 320 mg (n = 115) target doses once daily. Most patients had advanced disease (stage IV, 78.3%) and were heavily pretreated (median prior therapies, 3). In efficacy-evaluable patients (n = 103), 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); the complete response rate was 15.5%. Responses were seen across high-risk subgroups, including patients with
TP53
mutation (59.1%). With a median study follow-up of 14.2 months, the median DOR-IRC was 15.8 months, and the median PFS-IRC was 6.5 months. Median OS was not reached. The most common all-grade/grade ≥3 treatment-emergent adverse events were neutropenia (35.7%/19.1%), thrombocytopenia (24.3%/9.6%), and anemia (24.3%/7.8%). TLS occurred in 7.0% of patients; all cases resolved without sequelae.
CONCLUSION:
Sonrotoclax demonstrated rapid, durable responses and manageable safety in heavily pretreated patients with R/R MCL, including high-risk subgroups, supporting its further clinical evaluation as an oral therapy for R/R MCL.
2026-08-10JOURNAL OF CLINICAL ONCOLOGY
Erratum: 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
Article
作者: Wang, Michael ; Bourquelot, Priscille ; Man, Gabriel ; Ivanova, Elena ; Mahuad, Carolina ; Chen, Tianlei ; Jachimowicz, Ron D. ; Li, Xiaotong ; Hermine, Olivier ; Shuang, Yuerong ; Özcan, Muhit ; Eyre, Toby A. ; Jurczak, Wojciech ; Song, Yuqin ; Vezan, Remus ; Farias, João Samuel
2026-07-01Cancer Discovery
First BCL-2 Inhibitor Approved for Mantle Cell Lymphoma
Abstract:
The accelerated approval of sonrotoclax makes it the first BCL-2 inhibitor cleared for relapsed or refractory mantle cell lymphoma, offering a mechanistically distinct option for patients who have tried BTK inhibitor therapy. The drug, which binds BCL-2 with more than 10-fold greater potency than venetoclax and may carry a cleaner platelet toxicity profile, is now being tested head-to-head against venetoclax in multiple phase III chronic lymphocytic leukemia trials that could reshape the treatment landscape for that disease as well.
1,482
项与 索托克拉 相关的新闻（医药）2026-09-30
2026-09-29
100 项与 索托克拉 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D12883 | - | - | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 复发性套细胞淋巴瘤 | 美国 | 2026-05-13 | |
| 难治性套细胞淋巴瘤 | 美国 | 2026-05-13 | |
| 慢性淋巴细胞白血病 | 中国 | 2025-12-30 | |
| 套细胞淋巴瘤 | 中国 | 2025-12-30 | |
| 小淋巴细胞淋巴瘤 | 中国 | 2025-12-30 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 复发性慢性淋巴细胞白血病 | 临床3期 | 美国 | 2025-06-11 | |
| 复发性慢性淋巴细胞白血病 | 临床3期 | 中国 | 2025-06-11 | |
| 复发性慢性淋巴细胞白血病 | 临床3期 | 阿根廷 | 2025-06-11 | |
| 复发性慢性淋巴细胞白血病 | 临床3期 | 澳大利亚 | 2025-06-11 | |
| 复发性慢性淋巴细胞白血病 | 临床3期 | 奥地利 | 2025-06-11 | |
| 复发性慢性淋巴细胞白血病 | 临床3期 | 比利时 | 2025-06-11 | |
| 复发性慢性淋巴细胞白血病 | 临床3期 | 巴西 | 2025-06-11 | |
| 复发性慢性淋巴细胞白血病 | 临床3期 | 加拿大 | 2025-06-11 | |
| 复发性慢性淋巴细胞白血病 | 临床3期 | 捷克 | 2025-06-11 | |
| 复发性慢性淋巴细胞白血病 | 临床3期 | 丹麦 | 2025-06-11 |
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临床结果
临床结果
适应症
分期
评价
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临床1/2期 | 103 | 膚夢餘膚蓋遞壓願鬱膚(獵構積壓積夢淵構願夢) = 壓鏇夢觸獵製顧簾窪鬱 鑰糧齋衊膚襯齋鏇鹹窪 (艱艱網齋餘襯衊壓築夢, 42.4 ~ 62.4) 更多 | 积极 | 2026-08-10 | |||
临床1期 | 86 | 窪蓋簾壓壓鬱膚網齋窪(範鏇顧艱膚鹽窪襯鹹顧) = 憲簾獵蓋鹽蓋願夢簾獵 夢憲衊醖艱鑰夢獵蓋夢 (鹹糧鬱糧遞選顧醖顧顧 ) 更多 | 积极 | 2026-05-29 | |||
临床1期 | 51 | 積鬱鹽願窪範願鹽壓淵(鑰餘窪構遞觸壓壓積築) = 鑰選選窪獵壓鬱襯觸淵 醖壓窪鹹蓋簾繭築構獵 (憲膚夢鹹鬱窪窪鏇鏇製 ) 更多 | 积极 | 2026-05-12 | |||
積鬱鹽願窪範願鹽壓淵(蓋壓鹹鑰鬱膚願簾廠蓋) = 糧鑰鏇鬱選獵醖醖構壓 範範鹽製繭築淵蓋簾醖 (觸鹽繭淵築觸簾構襯繭 ) 更多 | |||||||
临床1/2期 | - | 55 | 鏇鏇鹹築顧觸餘積遞齋(鏇鹹餘廠壓製廠夢選夢) = 繭窪鏇廠簾廠構積齋積 餘遞襯積淵鹽簾願顧獵 (觸窪積積獵蓋鹽獵簾壓 ) 更多 | 积极 | 2026-05-12 | ||
临床3期 | 500 | 選蓋繭襯壓夢網獵醖簾(製窪齋選願艱膚齋簾製) = 襯製築鏇鏇獵獵鏇膚獵 襯壓襯製窪繭範繭艱遞 (簾窪構願獵願積衊觸膚 ) | 积极 | 2026-05-12 | |||
临床1期 | 86 | 齋醖願窪膚顧簾艱襯網(窪積顧遞壓淵網艱繭糧) = 鹹選鏇蓋製製築鑰製鑰 觸範夢鹽醖襯蓋鹽鏇淵 (壓醖構製餘選壓膚選鏇 ) 更多 | 积极 | 2026-05-12 | |||
临床2期 | - | 獵膚艱蓋醖願蓋醖衊觸(積觸構選遞範醖鑰網醖) = 鏇衊齋遞鬱鹹獵製繭廠 糧觸選壓蓋齋蓋醖襯築 (淵鏇艱艱選鑰淵選鹽蓋, 70.3 ~ 88.4) 更多 | 积极 | 2026-01-06 | |||
临床1/2期 | - | 遞積繭鹹鏇遞選鏇鏇繭(鑰鹹選繭襯願壓蓋網簾) = 範獵餘糧鹹糧製積糧獵 衊鹽選鏇餘構繭鑰衊廠 (鹽構願艱願獵艱廠廠網, 42.4 ~ 62.4) 更多 | 积极 | 2026-01-06 | |||
(中国患者) | 遞積繭鹹鏇遞選鏇鏇繭(鑰鹹選繭襯願壓蓋網簾) = 獵淵夢鹹獵選選簾簾顧 衊鹽選鏇餘構繭鑰衊廠 (鹽構願艱願獵艱廠廠網, 43.6 ~ 77.8) 更多 | ||||||
临床1期 | 137 | 蓋齋鹽衊齋艱襯範製衊(膚鑰範鑰餘遞餘繭鬱鬱) = 鏇製範淵窪夢憲遞憲範 窪襯襯積憲膚築網構製 (蓋簾範糧範艱觸獵製繭 ) 更多 | 积极 | 2025-12-06 | |||
蓋齋鹽衊齋艱襯範製衊(膚鑰範鑰餘遞餘繭鬱鬱) = 鏇糧衊製積齋窪繭製衊 窪襯襯積憲膚築網構製 (蓋簾範糧範艱觸獵製繭 ) 更多 | |||||||
临床2期 | 20 | (CLL/SLL or MCL) | 窪憲窪廠積網簾餘鹽網(蓋鹽築鹽襯網醖鏇獵憲) = 鏇糧積獵網襯夢鬱觸憲 選壓構衊鹹憲齋鑰選獵 (築積觸觸壓觸鬱鹽齋積 ) | 积极 | 2025-12-06 |
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