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)

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.

Study Overview

• Status: Recruiting
• Conditions: Relapsed/Refractory Multiple Myeloma
• Intervention / Treatment: Drug: Dexamethasone; Drug: Carfilzomib; Drug: Sonrotoclax; Drug: Daratumumab; Drug: Pomalidomide

Detailed Description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

• Study Type: Interventional
• Enrollment (Estimated): 246
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: BeOne Medicines; Phone Number: 1.877.828.5568; Email: clinicaltrials@beonemed.com

Study Locations

• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, ACT 2605
      • Recruiting
      • Canberra Hospital
  • New South Wales
    • Kingswood, New South Wales, Australia, NSW 2747
      • Recruiting
      • Nepean Hospital
  • Victoria
    • Clayton, Victoria, Australia, VIC 3168
      • Recruiting
      • Monash Health
    • Fitzroy, Victoria, Australia, VIC 3065
      • Recruiting
      • St Vincents Hospital Melbourne
    • Melbourne, Victoria, Australia, VIC 3004
      • Recruiting
      • The Alfred Hospital
  • Western Australia
    • Perth, Western Australia, Australia, WA 6000
      • Recruiting
      • Royal Perth Hospital
• Brazil
  • Brasília, Brazil, 70200-730
    • Recruiting
    • Hospital Sirio Libanes Brasilia
  • Brasília, Brazil, 70390140
    • Recruiting
    • Instituto Dor de Pesquisa E Ensino Distrito Federal
  • Porto Alegre, Brazil, 90110-270
    • Recruiting
    • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
  • Salvador, Brazil, 41253-190
    • Recruiting
    • Hospital Sao Rafael (Rede Dor)
  • São Paulo, Brazil, 05652-900
    • Recruiting
    • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
  • São Paulo, Brazil, 01308-050
    • Recruiting
    • Hospital Sirio Libanes
  • São Paulo, Brazil, 01401-004
    • Recruiting
    • Instituto Dor de Pesquisa E Ensino Sao Paulo
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Recruiting
      • Cross Cancer Institute
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Recruiting
      • British Columbia Cancer Agency the Vancouver Centre
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Princess Margaret Cancer Centre
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Recruiting
      • Peking University Peoples Hospital
    • Beijing, Beijing Municipality, China, 100000
      • Recruiting
      • Peking University Third Hospital
    • Beijing, Beijing Municipality, China, 100020
      • Recruiting
      • Beijing Chao Yang Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400030
      • Recruiting
      • Chongqing Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Completed
      • Fujian Medical University Union Hospital
    • Xiamen, Fujian, China, 361003
      • Completed
      • The first affiliated hospital of xiamen university
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat Sen University Cancer Center
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Completed
      • The Second Hospital of Hebei Medical University
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Henan Cancer Hospital
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • The first affiliated hospital of Zhengzhou university
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410013
      • Completed
      • Hunan Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Jiangsu Province Hospital
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
  • Jiangxi
    • Nanchang, Jiangxi, China, 332000
      • Recruiting
      • The First Affiliated Hospital of Nanchang University Branch Xianghu
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • Recruiting
      • The First Hospital of China Medical University
  • Shandong
    • Qingdao, Shandong, China, 266000
      • Recruiting
      • Qingdao Municipal Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Affiliated Zhongshan Hospital of Fudan University
    • Shanghai, Shanghai Municipality, China, 200434
      • Completed
      • Shanghai Fourth Peoples Hospital Affiliated to Tongji University
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 301617
      • Recruiting
      • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
    • Tianjin, Tianjin Municipality, China, 300052
      • Completed
      • Tianjin Medical University General Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The first Affiliated Hospital, Zhejiang University School of Medicine
• France
  • Lille, France, 59000
    • Recruiting
    • Hopital Claude Huriez Chu Lille
  • Nantes, France, 44000
    • Recruiting
    • Centre Hospitalier Universitaire Nantes Hotel Dieu
  • Poitiers, France, 86000
    • Recruiting
    • Chu de Poitiers Site de La Mileterie
• Germany
  • Aachen, Germany, 52074
    • Recruiting
    • Universitaetsklinikum Aachen
  • Dresden, Germany, 01307
    • Recruiting
    • Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
  • Hamburg, Germany, 20251
    • Recruiting
    • Universitatsklinikum Hamburg Eppendorf
  • Würzburg, Germany, 97080
    • Recruiting
    • Universitatsklinikum Wurzburg
• Greece
  • Alexandroupoli, Greece, 68100
    • Recruiting
    • University Hospital of Alexandroupolis
  • Athens, Greece, 115 28
    • Recruiting
    • General Hospital of Athens Alexandra
• Italy
  • Bari, Italy, 70124
    • Recruiting
    • Azienda Ospedaliera Policlinico Di Bari
  • Bologna, Italy, 40138
    • Recruiting
    • Policlinico Sorsola Malpighi, Aou Di Bologna
  • Meldola, Italy, 47014
    • Recruiting
    • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
  • Milan, Italy, 20141
    • Recruiting
    • Istituto Europeo di Oncologia
  • Torino, Italy, 10060
    • Recruiting
    • Istituto Di Candiolo Irccs
  • Torrette, Italy, 60020
    • Recruiting
    • Azienda Ospedaliera Universitaria Delle Marche
• Singapore
  • Singapore, Singapore, 119074
    • Recruiting
    • National University Hospital Singapore
• South Korea
  • Seoul Teugbyeolsi
    • GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
      • Recruiting
      • Samsung Medical Center
    • SeochoGu, Seoul Teugbyeolsi, South Korea, 06591
      • Recruiting
      • The Catholic University of Korea, Seoul St Marys Hospital
    • SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
      • Recruiting
      • Severance Hospital Yonsei University Health System
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Recruiting
      • Seoul National University Hospital
    • SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
      • Recruiting
      • Asan Medical Center
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic de Barcelona
  • Cáceres, Spain, 10002
    • Recruiting
    • Hospital San Pedro De Alcantara
  • Málaga, Spain, 29010
    • Recruiting
    • Hospital Universitario Virgen de la Victoria
  • Seville, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocio
• United Kingdom
  • Headington, United Kingdom, OX3 7LE
    • Recruiting
    • Oxford University Hospitals Nhs Trust Churchill Hospital
  • London, United Kingdom, NW1 2PG
    • Recruiting
    • University College Hospital
  • Sutton, United Kingdom, SM2 5PT
    • Recruiting
    • Royal Marsden Nhs Foundation Royal Marsden Hospital
  • Truro, United Kingdom, TR1 3LJ
    • Recruiting
    • Royal Cornwall Hospitalsnhs Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0004
      • Recruiting
      • University of Alabama At Birmingham Hospital
  • California
    • Duarte, California, United States, 91010-3012
      • Recruiting
      • City of Hope National Medical Center
    • Irvine, California, United States, 92618-2377
      • Recruiting
      • City of Hope Irvine Lennar
  • Florida
    • Miami, Florida, United States, 33136-2107
      • Recruiting
      • University of Miami
  • Georgia
    • Atlanta, Georgia, United States, 30322-1013
      • Recruiting
      • Emory University Winship Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60637-1443
      • Recruiting
      • University of Chicago Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Completed
      • Massachusetts General Hospital
  • Missouri
    • St Louis, Missouri, United States, 63110-1010
      • Recruiting
      • Washington University School of Medicine
  • New Jersey
    • Hackensack, New Jersey, United States, 07601-1915
      • Recruiting
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10065-6800
      • Recruiting
      • Memorial Sloan Kettering Cancer Center Mskcc
    • New York, New York, United States, 10065-4870
      • Recruiting
      • Weill Cornell Medical College Newyork Presbyterian Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210-1240
      • Recruiting
      • The James Cancer Hospital and Solove Research Institute At Ohio State University
  • Utah
    • Salt Lake City, Utah, United States, 84112-5550
      • Recruiting
      • Huntsman Cancer Institute
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington
  • Wisconsin
    • Madison, Wisconsin, United States, 53792-0001
      • Recruiting
      • University of Wisconsin Carbone Cancer Center
    • Milwaukee, Wisconsin, United States, 53226-1222
      • Recruiting
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
2. A confirmed diagnosis of multiple myeloma (must have an M-component in serum and/or urine)

3. 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

4. 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.

   1. 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.
   2. 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.
   3. 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

5. 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.

6. Adequate organ function defined as:

   1. Hemoglobin ≥ 8.0 g/dL within 7 days before first dose of study treatment, (transfusions, in accordance with institutional guidelines, are permitted)
   2. Platelet count ≥ 75,000/μL, within 7 days before first dose of study treatment, independent of growth factor support and transfusions
   3. Absolute neutrophil count (ANC) ≥ 1000/mm^3 within 7 days before first dose of study treatment
   4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN) and total bilirubin ≤ 2.0 x ULN N (total bilirubin must be < 3 x ULN for patients with Gilbert's syndrome)

Exclusion Criteria:

1. Participant has any of the following conditions:

   1. Non secretory MM (Serum free light chains < 10 mg/dL)
   2. Solitary plasmacytoma
   3. Active plasma cell leukemia (ie, either 20% of peripheral white blood cells or > 2.0 x 109/L circulating plasma cells by standard differential)
   4. Waldenström macroglobulinemia (WM)
   5. Amyloidosis.
   6. Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome
   7. Chronic respiratory disease that requires continuous oxygen

2. Significant cardiovascular disease, including but not limited to:

   1. Myocardial infarction ≤ 6 months before screening
   2. Ejection fraction ≤ 50%
   3. Unstable angina≤ 3 months before screening
   4. New York Heart Association Class III or IV congestive heart failure
   5. History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
   6. Heart rate-corrected QT interval > 480 milliseconds based on Fridericia's formula
   7. History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
   8. Uncontrolled hypertension at screening, defined as systolic blood pressure > 170 mmHg and diastolic blood pressure > 105 mmHg by ≥ 2 consecutive measurements. Prior therapy with sonrotoclax or other agents inhibiting BCL2 activity (eg, venetoclax)
3. Known infection with human immunodeficiency virus (HIV)

4. Serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows:

   1. Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Participants with presence of HBcAb, but absence of HBsAg, are eligible if HBV DNA is undetectable (limitation of sensitivity < 20 IU/mL) ,), and if they are willing to undergo monthly monitoring for HBV reactivation.
   2. Presence of HCV antibody. Participants with presence of HCV antibody are eligible if HCV RNA is undetectable (limitation of sensitivity < 15 IU/mL).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 Dose Escalation; Dose-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.	Drug: Dexamethasone; Once weekly either orally or intravenously; Drug: Carfilzomib; Administered intravenously weekly; Drug: Sonrotoclax; Administered orally daily; Other Names: BGB-11417; Drug: Daratumumab; Administered subcutaneously weekly; Drug: Pomalidomide; Administered orally daily
Experimental: Part 2 Cohort Expansion; There 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	Drug: Dexamethasone; Once weekly either orally or intravenously; Drug: Carfilzomib; Administered intravenously weekly; Drug: Sonrotoclax; Administered orally daily; Other Names: BGB-11417

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Part 1: At Steady-state: trough plasma concentration (Ctrough) ss		Cycle 2 (each cycle is up to 28 days)
Part 1: At Steady-state: time to reach Cmax (tmax,ss)		Cycle 2 (each cycle is up to 28 days)
Part 2: Time to response (TTR) as Assessed by Investigator	TTR is defined as the time from start of treatment (for nonrandomized cohorts) or date of randomization (for randomized cohorts to first documentation of response of Partial Response (PR) or better	Approximately 4 years
Part 2: Duration of response (DOR) as Assessed by Investigator	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. DOR will be analyzed only for patients who have achieved an overall response of at least PR. The distribution of DOR will be summarized by the Kaplan-Meier method.	Approximately 4 years
Part 2: Progression-free survival (PFS) as Assessed by Investigator	PFS is defined as time from start of treatment （for nonrandomized cohorts） or date of randomization （for randomized cohorts） to the first documentation of disease progression or death, whichever occurs first	Approximately 4 years
Part 2: Overall survival (OS) as Assessed by Investigator	OS defined as the time from start of treatment (for nonrandomized cohorts) or date of randomization (for randomized cohorts to the date of death due to any cause	Approximately 4 years

Collaborators and Investigators

• Sponsor: BeOne Medicines

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Dexamethasone; carfilzomib; pomalidomide; daratumumab
• Other Study ID Numbers: BGB-11417-105; 2021-003614-39 (EudraCT Number); U1111-1277-5444 (Other Identifier: UTN Number); 2023-507751-30-00 (Ctis); CTR20231932 (Other Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

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

IPD 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.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No