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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Mantle Cell Lymphoma; Relapsed Mantle Cell Lymphoma; Refractory Mantle Cell Lymphoma (MCL)
• Intervention / Treatment: Drug: BGB-11417

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1118
    • Hospital Aleman
• Belgium
  • Bruges, Belgium, 8000
    • AZ Sint Jan Brugge
  • Ghent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Leuven, Belgium, 3000
    • University Hospitals Leuven
  • Roeselare, Belgium, 8800
    • AZ Delta
• Brazil
  • Curitiba, Brazil, 81520-060
    • Hospital Erasto Gaertner
  • Porto Alegre, Brazil, 90110-270
    • Hospital Mae de Deus
  • Ribeirão Preto, Brazil, 14051-140
    • Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
  • Rio de Janeiro, Brazil, 22250-905
    • Oncoclinicas Rio de Janeiro Sa
  • Rio de Janeiro, Brazil, 22775-001
    • Instituto Americas Ensino, Pesquisa E Inovacao
  • Salvador, Brazil, 41253-190
    • Hospital Sao Rafael (Rede Dor)
  • São Paulo, Brazil, 01323-001
    • Hospital Beneficência Portuguesa de São Paulo
  • São Paulo, Brazil, 01401-002
    • Instituto Dor de Pesquisa E Ensino Sao Paulo
  • São Paulo, Brazil, 01508-010
    • Accamargo Cancer Center
  • São Paulo, Brazil, 05402-000
    • Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
  • São Paulo, Brazil, 05653-120
    • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Qeii Health Science Center
• China
  • Anhui
    • Hefei, Anhui, China, 230088
      • Anhui Provincial Cancer Hospital aka West Branch of Anhui Province Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing Municipality, China, 100029
      • China Japan Friendship Hospital
    • Beijing, Beijing Municipality, China, 101100
      • Beijing Friendship Hospital, Capital Medical University(Tongzhou)
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat Sen University Cancer Center
    • Guangzhou, Guangdong, China, 510120
      • Guangdong Provincial Peoples Hospital Huifu Branch
    • Jiangmen, Guangdong, China, 529030
      • Jiangmen Central Hospital
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The Tumor Hospital Affiliated to Guangxi Medical University
  • Guizhou
    • Guiyang, Guizhou, China, 550000
      • Cancer Hospital of Guizhou Medical University
  • Hainan
    • Haikou, Hainan, China, 570206
      • Hainan General Hospital
  • Henan
    • Zhengzhou, Henan, China, 450052
      • The first affiliated hospital of Zhengzhou university
    • Zhengzhou, Henan, China, 450000
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
    • Nantong, Jiangsu, China, 201203
      • Affiliated Hospital of Nantong University
    • Xuzhou, Jiangsu, China, 221000
      • The Affiliated Hospital of Xuzhou Medical University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University Branch Donghu
    • Nanchang, Jiangxi, China, 330029
      • Jiangxi Province Cancer Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Liaoning Cancer Hospital and Institute
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • General Hospital of Ningxia Medical University
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital
    • Qingdao, Shandong, China, 266555
      • The Affiliated Hospital of Qingdao University Branch West Coast
  • Shanxi
    • Taiyuan, Shanxi, China, 030013
      • Shanxi Provincial Cancer hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital
    • Tianjin, Tianjin Municipality, China, 300020
      • Institute of Hematology and Hospital of Blood Disease
  • Xinjiang
    • Kashgar, Xinjiang, China, 844099
      • The First Peoples Hospital of Kashgar
    • Ürümqi, Xinjiang, China, 830000
      • Affiliated Cancer Hospital of Xinjiang Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310003
      • The first Affiliated Hospital, Zhejiang University School of Medicine
• France
  • Le Mans, France, 72037
    • Centre Hospitalier Le Mans
  • Nantes, France, 44093
    • Centre Hospitalier Universitaire Nantes Hotel Dieu
  • Paris, France, 75015
    • Necker University Hospital
  • Paris, France, 75013
    • Hopital Pitie Salpetriere Service Hematologie
  • PierreBenite, France, 69495
    • Chu Hopital Lyon Sud
  • Tours, France, 37000
    • Chu Tours Hopital Bretonneau Service Pneumologie
• Germany
  • Cologne, Germany, 50937
    • Universitatsklinikum Koln, Innere Medizin I
  • Düsseldorf, Germany, 40225
    • Universitatsklinikum Dusseldorf
  • Essen, Germany, D-45147
    • Universitatsklinikum Essen (Aor)
  • Kiel, Germany, 24105
    • Universitatsklinikum Schleswig Holstein, Campus Kiel
• Israel
  • Ashdod, Israel, 7747629
    • Assuta Ashdod Medical Center
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
  • Jerusalem, Israel, 9112001
    • Hadassah En Karem Medical Center
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center
  • Tel Aviv, Israel, 5262100
    • Sheba Medical Center
  • Tel Aviv, Israel, 64239
    • Sourasky Tel Aviv Medical Center
• Italy
  • Bari, Italy, 70124
    • IRCCS Istituto Tumori Giovanni Paolo II
  • Bologna, Italy, 40138
    • Policlinico Sorsola Malpighi, Aou Di Bologna
  • Brescia, Italy, 25123
    • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
  • Meldola, Italy, 47014
    • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
  • Novara, Italy, 28100
    • AOU Maggiore della Carità
• Poland
  • Gdansk, Poland, 80-952
    • Uniwersyteckie Centrum Kliniczne
  • Krakow, Poland, 30-727
    • Pratia MCM Krakow
  • Lublin, Poland, 20-090
    • Uniwersytecki Szpital Kliniczny Nr W Lublinie
  • Warsaw, Poland, 02-034
    • Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy
• Puerto Rico
  • San Juan, Puerto Rico, 00917
    • Auxilio Mutuo Cancer Center
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall dHebron
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06620
    • Ankara University Medical Faculty
  • Ankara, Turkey (Türkiye), 06620
    • Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
  • Ankara, Turkey (Türkiye), 6500
    • Gazi University
  • Atakum Samsun, Turkey (Türkiye), 55200
    • Ondokuz Mayis University Medicine Faculty Hospital
  • Istanbul, Turkey (Türkiye), 34214
    • Bagcilar Medipol Mega Hospital
  • Istanbul, Turkey (Türkiye), 34365
    • Vkv American Hospital
  • Izmir, Turkey (Türkiye), 35100
    • Ege University Medical Faculty
  • Kayseri, Turkey (Türkiye), 38039
    • Erciyes University School of Medicine
  • Kocaeli, Turkey (Türkiye), 41380
    • Kocaeli Universitesi Tip Fakultesi
• United Kingdom
  • Greater Manchester, United Kingdom, M20 4BX
    • The Christie Hospital
  • Headington, United Kingdom, OX3 7LE
    • Churchill Hospital Oxford University Hospital Nhs Trust
  • London, United Kingdom, NW1 2PG
    • University College Hospital
  • Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
    • Clatterbridge Cancer Centre
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama At Birmingham Hospital
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Medical Oncology and Hematology
  • Iowa
    • Des Moines, Iowa, United States, 50309
      • Des Moines Oncology Research Association
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane Cancer Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Luminis Health Anne Arundel Medical Center
    • Columbia, Maryland, United States, 21044
      • Maryland Oncology Hematology, PA
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Hospital, Ellis Fischel Cancer Center
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Nebraska Cancer Specialists
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Cancer Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Hematology Charlotte
  • Texas
    • Houston, Texas, United States, 77030-4009
      • The University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; Participants will receive sonrotoclax	Drug: BGB-11417; Administered orally; Other Names: sonrotoclax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 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
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 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

Collaborators and Investigators

• Sponsor: BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2022
• Primary Completion (Actual): July 18, 2025
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Lymphoma; MCL; Mantle Cell Lymphoma; Relapsed Mantle Cell Lymphoma; Refractory Mantle Cell Lymphoma; Refractory MCL
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Hemic and Lymphatic Diseases; Lymphoma; Lymphoma, Mantle-Cell
• Other Study ID Numbers: BGB-11417-201; CTR20221815 (Other Identifier: ChinaDrugTrials); 2022-500687-35-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No