A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma
A Phase 1b/2 Dose-Escalation and Cohort-Expansion Study to Determine the Safety and Efficacy of BGB-11417as Monotherapy, in Combination With Dexamethasone, Dexamethasone/Carfilzomib, Dexamethasone/Daratumumab, and Dexamethasone/Pomalidomide in Patients With Relapsed/Refractory Multiple Myeloma and t(11;14)
5 other identifiers
interventional
246
13 countries
83
Brief Summary
The purpose of this study is to assess the safety, tolerability, and efficacy of sonrotoclax as monotherapy and in various combinations in patients with relapsed/refractory (R/R) multiple myeloma (MM) and chromosomal translocation t(11;14). The study investigates sonrotoclax alone and in combination with dexamethasone and other agents, including carfilzomib, daratumumab, and pomalidomide.
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 2021
Longer than P75 for phase_1
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2021
CompletedFirst Posted
Study publicly available on registry
July 22, 2021
CompletedStudy Start
First participant enrolled
September 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
April 22, 2026
April 1, 2026
5.1 years
July 7, 2021
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)
DLTs will be based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and will include most grade 3 or higher events, as defined in the protocol.
Up to 28 days
Part 1 And 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events Leading to Discontinuation and Adverse Events of Special Interest (AESIs).
Up to 30 days after last dose of study drug
Part 2: Overall response rate (ORR) as Assessed by Investigator
Defined as the percentage of participants who achieved a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per International Myeloma Working Group (IMWG) criteria
Approximately 4 years
Part 2: Very Good Partial Response (VGPR) or Better Response Rate as Assessed by Investigator
Defined as the percentage of participants with a documented VGPR or better (including sCR, CR, and VGPR)
Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 4 years]
Part 2: Complete Response (CR) or Stringent Complete Response (sCR) as Assessed by Investigator
defined as the percentage of participants with a documented CR or sCR
Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 4 years])
Secondary Outcomes (11)
Part 1: Area under the plasma concentration-time curve time 0 to the last measurable concentration (AUClast) After a Single Dose of Sonrotoclax
Cycle 1 (each cycle is up to 28 days)
Part 1: Maximum observed plasma concentration (Cmax) After a Single Dose of Sonrotoclax
Cycle 1 (each cycle is up to 28 days)
Part 1: Time to reach Cmax (tmax) After a Single Dose of Sonrotoclax
Cycle 1 (each cycle is up to 28 days)
Part 1: At Steady-state: AUC last, ss
Cycle 2 (each cycle is up to 28 days)
Part 1: At Steady-state: Cmax, ss
Cycle 2 (each cycle is up to 28 days)
- +6 more secondary outcomes
Study Arms (2)
Part 1 Dose Escalation
EXPERIMENTALDose-escalation and de-escalation to determine maximum tolerated dose (MTD) of sonrotoclax plus dexamethasone, sonrotoclax plus dexamethasone plus carfilzomib, sonrotoclax plus dexamethasone plus daratumumab, and sonrotoclax plus dexamethasone plus pomalidomide.
Part 2 Cohort Expansion
EXPERIMENTALThere will be up to 7 expansion cohorts to further evaluate the safety and efficacy of sonrotoclax monotherapy, sonrotoclax plus dexamethasone in combination with dexamethasone plus carfilzomib, and in combination with dexamethasone plus daratumumab
Interventions
Administered orally daily
Once weekly either orally or intravenously
Eligibility Criteria
You may qualify if:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- A confirmed diagnosis of multiple myeloma (must have an M-component in serum and/or urine)
- Measurable disease defined as:
- i. M-spike ≥ 500mg/dL, or ii. Urine protein M-spike of ≥ 200 mg/day, or iii. Serum free light chains ≥ 10 mg/dL, and an abnormal κ:λ ratio
- Participant has documented relapsed or progressive MM on or after any regimen or who are refractory to the most recent line of therapy.
- i. Relapsed MM is defined as previously treated MM that progresses and requires initiation of salvage therapy but does not meet the criteria for refractory MM.
- ii. Refractory MM is defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy or progresses within 60 days of last therapy.
- In Part 1 and Part 2 Cohorts 1 and 2 participants should have relapsed or progressive disease and have had ≥ 3 prior lines of therapy including a proteasome inhibitor, an IMiD, and an anti-CD38 monoclonal antibody, and no more available approved therapies.
- Participants in Part 2 Cohorts 3, 4, and 5 should have relapsed or progressive disease and have had ≥ 1 prior line of therapy. Prior treatment with carfilzomib is allowed but the patient must not be considered carfilzomib refractory by the investigator.
- Participants in Part 2 Cohorts 6 and 7 should have relapsed or progressive disease and have had 1 to 3 prior lines of therapy and previously treated with a proteasome inhibitor and an IMiD
- Positivity for t(11;14) translocation must be confirmed by validated fluorescence in situ hybridization (FISH) testing assay in a pre-defined laboratory
- a. fresh bone marrow aspirate sample must be collected at screening and sent to central laboratory for t(11;14) FISH testing.
- Adequate organ function defined as:
- Hemoglobin ≥ 8.0 g/dL within 7 days before first dose of study treatment, (transfusions, in accordance with institutional guidelines, are permitted)
- Platelet count ≥ 75,000/μL, within 7 days before first dose of study treatment, independent of growth factor support and transfusions
- +2 more criteria
You may not qualify if:
- Participant has any of the following conditions:
- Non secretory MM (Serum free light chains \< 10 mg/dL)
- Solitary plasmacytoma
- Active plasma cell leukemia (ie, either 20% of peripheral white blood cells or \> 2.0 x 109/L circulating plasma cells by standard differential)
- Waldenström macroglobulinemia (WM)
- Amyloidosis.
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome
- Chronic respiratory disease that requires continuous oxygen
- Significant cardiovascular disease, including but not limited to:
- Myocardial infarction ≤ 6 months before screening
- Ejection fraction ≤ 50%
- Unstable angina≤ 3 months before screening
- New York Heart Association Class III or IV congestive heart failure
- History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
- Heart rate-corrected QT interval \> 480 milliseconds based on Fridericia's formula
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeOne Medicineslead
Study Sites (83)
University of Alabama At Birmingham Hospital
Birmingham, Alabama, 35294-0004, United States
City of Hope National Medical Center
Duarte, California, 91010-3012, United States
City of Hope Irvine Lennar
Irvine, California, 92618-2377, United States
University of Miami
Miami, Florida, 33136-2107, United States
Emory University Winship Cancer Center
Atlanta, Georgia, 30322-1013, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Washington University School of Medicine
St Louis, Missouri, 63110-1010, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601-1915, United States
Weill Cornell Medical College Newyork Presbyterian Hospital
New York, New York, 10065-4870, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, 10065-6800, United States
The James Cancer Hospital and Solove Research Institute At Ohio State University
Columbus, Ohio, 43210-1240, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550, United States
University of Washington
Seattle, Washington, 98195, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792-0001, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-1222, United States
Canberra Hospital
Garran, Australian Capital Territory, ACT 2605, Australia
Nepean Hospital
Kingswood, New South Wales, NSW 2747, Australia
Monash Health
Clayton, Victoria, VIC 3168, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, VIC 3065, Australia
The Alfred Hospital
Melbourne, Victoria, VIC 3004, Australia
Royal Perth Hospital
Perth, Western Australia, WA 6000, Australia
Hospital Sirio Libanes Brasilia
Brasília, 70200-730, Brazil
Instituto Dor de Pesquisa E Ensino Distrito Federal
Brasília, 70390140, Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, 90110-270, Brazil
Hospital Sao Rafael (Rede Dor)
Salvador, 41253-190, Brazil
Hospital Sirio Libanes
São Paulo, 01308-050, Brazil
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, 01401-004, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652-900, Brazil
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Peking University Third Hospital
Beijing, Beijing Municipality, 100000, China
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, 100020, China
Peking University Peoples Hospital
Beijing, Beijing Municipality, 100044, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi, 332000, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Qingdao Municipal Hospital
Qingdao, Shandong, 266000, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
Shanghai Fourth Peoples Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, 200434, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
Tianjin, Tianjin Municipality, 301617, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Hopital Claude Huriez Chu Lille
Lille, 59000, France
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, 44000, France
Chu de Poitiers Site de La Mileterie
Poitiers, 86000, France
Universitaetsklinikum Aachen
Aachen, 52074, Germany
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
Dresden, 01307, Germany
Universitatsklinikum Hamburg Eppendorf
Hamburg, 20251, Germany
Universitatsklinikum Wurzburg
Würzburg, 97080, Germany
University Hospital of Alexandroupolis
Alexandroupoli, 68100, Greece
General Hospital of Athens Alexandra
Athens, 115 28, Greece
Azienda Ospedaliera Policlinico Di Bari
Bari, 70124, Italy
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, 40138, Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
Meldola, 47014, Italy
Istituto Europeo Di Oncologia
Milan, 20141, Italy
Istituto Di Candiolo Irccs
Torino, 10060, Italy
Azienda Ospedaliera Universitaria Delle Marche
Torrette, 60020, Italy
National University Hospital Singapore
Singapore, 119074, Singapore
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, 06351, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, 06591, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, 05505, South Korea
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital San Pedro de Alcantara
Cáceres, 10002, Spain
Hospital Universitario Virgen de La Victoria
Málaga, 29010, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Oxford University Hospitals Nhs Trust Churchill Hospital
Headington, OX3 7LE, United Kingdom
University College Hospital
London, NW1 2PG, United Kingdom
Royal Marsden Nhs Foundation Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
Royal Cornwall Hospitalsnhs Trust
Truro, TR1 3LJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2021
First Posted
July 22, 2021
Study Start
September 16, 2021
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.