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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20221815 | Other Identifier | ChinaDrugTrials | |
| 2022-500687-35-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Participants will receive sonrotoclax |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-11417 | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs) | Up to 1 Year | |
| Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation. | Up to 5 Years | |
| Part 1: Number of participants experiencing tumor lysis syndrome (TLS) relevant events | Up to 5 Years | |
| Part 2: Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC) | Defined as the proportion of participants who achieved a complete response (CR), or partial response (PR) per the Lugano Classification | Up to 4 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Single Dose Area Under the Plasma Concentration Time Curve (AUC) | Up to 2 Years | |
| Part 1: Single Dose Maximum Observed Plasma Concentration (Cmax) | Up to 2 Years | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama At Birmingham Hospital | Birmingham | Alabama | 35294 | United States | ||
| Medstar Georgetown University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42385124 | Derived | 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. |
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| Part 1: Single Dose Time to reach Cmax (Tmax) |
| Up to 2 Years |
| Part 1: Steady State Area Under the Plasma Concentration Time Curve (AUC) | Up to 2 Years |
| Part 1: Steady State Maximum Observed Plasma Concentration (Cmax) | Up to 2 Years |
| Part 1: Steady State Trough Plasma Concentration (CTrough) | Up to 2 Years |
| Part 1: Steady State Time to reach Cmax (Tmax) | Up to 2 Years |
| Overall Response Rate (ORR) as assessed by investigator | Defined as the proportion of participants who achieved a complete response (CR), or partial response (PR) per Lugano classification | Up to 4 Years |
| Duration of Response (DOR) as assessed by investigator and IRC | 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 | Up to 4 Years |
| Progression Free Survival (PFS) as assessed by investigator and IRC | 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. | Up to 4 Years |
| Time to Response (TTR) as assessed by investigator and IRC | TTR is defined as the time from start of treatment to first documentation of response of Partial Response (PR) or better | Up to 4 Years |
| Overall Survival (OS) | Defined as time from the start of treatment to the date of death due to any cause | Up to 4 Years |
| Part 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation. | Up to 4 Years |
| Part 2: Number of participants with clinically significant changes from baseline in vital signs | Vital signs include blood pressure and pulse rate | Up to 4 Years |
| Part 2: Number of participants with clinically significant changes from baseline in clinical laboratory values | Laboratory values include hematology, and clinical chemistry | Up to 4 Years |
| Part 2: Number of Participants With Clinically Significant Physical Examination Findings | A Physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems | Up to 4 Years |
| Part 2: Participant Reported Outcomes as measured by NFLymSI-18 | The National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index-18 (FLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score. | Up to 4 Years |
| Part 2: Participant Reported Outcomes as measured by EQ-5D-5L questionnaires | The EQ-5D-5L descriptive system assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) on which the participant rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). | Up to 4 Years |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46804 | United States |
| Des Moines Oncology Research Association | Des Moines | Iowa | 50309 | United States |
| Tulane Cancer Center | New Orleans | Louisiana | 70112 | United States |
| Luminis Health Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
| Maryland Oncology Hematology, Pa | Columbia | Maryland | 21044 | United States |
| University of Missouri Hospital, Ellis Fischel Cancer Center | Columbia | Missouri | 65212 | United States |
| Nebraska Cancer Specialists | Grand Island | Nebraska | 68803 | United States |
| Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Novant Health Hematology Charlotte | Charlotte | North Carolina | 28204 | United States |
| The University of Texas Md Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| Hospital Aleman | Buenos Aires | C1118 | Argentina |
| Az Sint Jan Brugge | Bruges | 8000 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| University Hospitals Leuven | Leuven | 3000 | Belgium |
| AZ DELTA | Roeselare | 8800 | Belgium |
| Hospital Erasto Gaertner | Curitiba | 81520-060 | Brazil |
| Hospital Mae de Deus | Porto Alegre | 90110-270 | Brazil |
| Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp | Ribeirão Preto | 14051-140 | Brazil |
| Oncoclinicas Rio de Janeiro Sa | Rio de Janeiro | 22250-905 | Brazil |
| Instituto Americas Ensino, Pesquisa E Inovacao | Rio de Janeiro | 22775-001 | Brazil |
| Hospital Sao Rafael (Rede Dor) | Salvador | 41253-190 | Brazil |
| Hospital Beneficencia Portuguesa de Sao Paulo | São Paulo | 01323-001 | Brazil |
| Instituto Dor de Pesquisa E Ensino Sao Paulo | São Paulo | 01401-002 | Brazil |
| Accamargo Cancer Center | São Paulo | 01508-010 | Brazil |
| Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular | São Paulo | 05402-000 | Brazil |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein | São Paulo | 05653-120 | Brazil |
| Qeii Health Science Center | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital | Hefei | Anhui | 230088 | China |
| China Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Beijing Friendship Hospital, Capital Medical University(Tongzhou) | Beijing | Beijing Municipality | 101100 | China |
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
| Sun Yat Sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Guangdong Provincial Peoples Hospital Huifu Branch | Guangzhou | Guangdong | 510120 | China |
| Jiangmen Central Hospital | Jiangmen | Guangdong | 529030 | China |
| The Tumor Hospital Affiliated to Guangxi Medical University | Nanning | Guangxi | 530021 | China |
| Cancer Hospital of Guizhou Medical University | Guiyang | Guizhou | 550000 | China |
| Hainan General Hospital | Haikou | Hainan | 570206 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| Affiliated Hospital of Nantong University | Nantong | Jiangsu | 201203 | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221000 | China |
| The First Affiliated Hospital of Nanchang University Branch Donghu | Nanchang | Jiangxi | 330006 | China |
| Jiangxi Province Cancer Hospital | Nanchang | Jiangxi | 330029 | China |
| Liaoning Cancer Hospital and Institute | Shenyang | Liaoning | 110042 | China |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 750004 | China |
| Shandong Cancer Hospital | Jinan | Shandong | 250117 | China |
| The Affiliated Hospital of Qingdao University Branch West Coast | Qingdao | Shandong | 266555 | China |
| Shanxi Provincial Cancer Hospital | Taiyuan | Shanxi | 030013 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| Institute of Hematology and Hospital of Blood Disease | Tianjin | Tianjin Municipality | 300020 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| The First Peoples Hospital of Kashgar | Kashgar | Xinjiang | 844099 | China |
| Affiliated Cancer Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 830000 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Centre Hospitalier Le Mans | Le Mans | 72037 | France |
| Centre Hospitalier Universitaire Nantes Hotel Dieu | Nantes | 44093 | France |
| Hopital Pitie Salpetriere Service Hematologie | Paris | 75013 | France |
| Necker University Hospital | Paris | 75015 | France |
| Chu Hopital Lyon Sud | PierreBenite | 69495 | France |
| Chu Tours Hopital Bretonneau Service Pneumologie | Tours | 37000 | France |
| Universitatsklinikum Koln, Innere Medizin I | Cologne | 50937 | Germany |
| Universitatsklinikum Dusseldorf | Düsseldorf | 40225 | Germany |
| Universitatsklinikum Essen (Aor) | Essen | D-45147 | Germany |
| Universitatsklinikum Schleswig Holstein, Campus Kiel | Kiel | 24105 | Germany |
| Assuta Ashdod Medical Center | Ashdod | 7747629 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Hadassah En Karem Medical Center | Jerusalem | 9112001 | Israel |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| Sheba Medical Center | Tel Aviv | 5262100 | Israel |
| Sourasky Tel Aviv Medical Center | Tel Aviv | 64239 | Israel |
| Irccs Istituto Tumori Giovanni Paolo Ii | Bari | 70124 | Italy |
| Policlinico Sorsola Malpighi, Aou Di Bologna | Bologna | 40138 | Italy |
| Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia | Brescia | 25123 | Italy |
| Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst | Meldola | 47014 | Italy |
| Aou Maggiore Della Carita | Novara | 28100 | Italy |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-952 | Poland |
| Pratia McM Krakow | Krakow | 30-727 | Poland |
| Uniwersytecki Szpital Kliniczny Nr W Lublinie | Lublin | 20-090 | Poland |
| Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy | Warsaw | 02-034 | Poland |
| Auxilio Mutuo Cancer Center | San Juan | 00917 | Puerto Rico |
| Hospital Universitario Vall Dhebron | Barcelona | 08035 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | 41013 | Spain |
| Ankara University Medical Faculty | Ankara | 06620 | Turkey (Türkiye) |
| Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital | Ankara | 06620 | Turkey (Türkiye) |
| Gazi University | Ankara | 6500 | Turkey (Türkiye) |
| Ondokuz Mayis University Medicine Faculty Hospital | Atakum Samsun | 55200 | Turkey (Türkiye) |
| Bagcilar Medipol Mega Hospital | Istanbul | 34214 | Turkey (Türkiye) |
| Vkv American Hospital | Istanbul | 34365 | Turkey (Türkiye) |
| Ege University Medical Faculty | Izmir | 35100 | Turkey (Türkiye) |
| Erciyes University School of Medicine | Kayseri | 38039 | Turkey (Türkiye) |
| Kocaeli Universitesi Tip Fakultesi | Kocaeli | 41380 | Turkey (Türkiye) |
| The Christie Hospital | Greater Manchester | M20 4BX | United Kingdom |
| Churchill Hospital Oxford University Hospital Nhs Trust | Headington | OX3 7LE | United Kingdom |
| University College Hospital | London | NW1 2PG | United Kingdom |
| Clatterbridge Cancer Centre | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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