Study of 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
3 other identifiers
interventional
125
15 countries
104
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2022
Longer than P75 for phase_1
104 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2022
CompletedFirst Posted
Study publicly available on registry
July 25, 2022
CompletedStudy Start
First participant enrolled
September 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
ExpectedSeptember 9, 2025
September 1, 2025
2.9 years
July 21, 2022
September 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (18)
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
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
- +13 more secondary outcomes
Study Arms (1)
Single Arm
EXPERIMENTALParticipants will receive sonrotoclax
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of MCL
- 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).
- Relapsed/refractory disease
- Presence of measurable disease
- Availability of archival tissue confirming diagnosis of MCL, or willing to undergo fresh tumor biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
- Adequate organ function
You may not qualify if:
- Known central nervous system involvement by lymphoma
- 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.
- Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199).
- 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.
- Clinically significant cardiovascular disease.
- Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
- Active fungal, bacterial or viral infection requiring systemic treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (104)
University of Alabama At Birmingham Hospital
Birmingham, Alabama, 35294, United States
Medstar Georgetown University Hospital
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2022
First Posted
July 25, 2022
Study Start
September 5, 2022
Primary Completion
July 18, 2025
Study Completion (Estimated)
January 31, 2027
Last Updated
September 9, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share