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New hope for multiple myeloma: sonrotoclax trial targets resistant cancer

NCT ID NCT04973605

Disease control Sponsor: BeOne Medicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 9 times

Summary

This study tests a new drug called sonrotoclax, alone or with other medicines, in people with a type of multiple myeloma that has come back or stopped responding to treatment. The trial includes 246 participants and aims to find the safest and most effective dose. Researchers will monitor side effects and measure how well the cancer responds.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sonrotoclax (also called BGB-11417), a drug taken by mouth
What this could lead to
If successful, this could provide a new treatment option for people with a specific type of multiple myeloma that has stopped responding to other therapies.
What could go wrong
This is an early-phase trial (1b/2) with a small number of participants, so results may not apply to everyone. The drug may cause side effects or not work as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 246 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma refractory plasma cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed/refractory multiple myeloma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    69 sites in 13 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Affiliated Zhongshan Hospital of Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Asan Medical Center

    RECRUITING

    SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

  • Azienda Ospedaliera Policlinico Di Bari

    RECRUITING

    Bari, 70124, Italy

  • Azienda Ospedaliera Universitaria Delle Marche

    RECRUITING

    Ancona, 60020, Italy

  • Beijing Chao Yang Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100020, China

  • British Columbia Cancer Agency the Vancouver Centre

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Canberra Hospital

    RECRUITING

    Garran, Australian Capital Territory, ACT 2605, Australia

  • Centre Hospitalier Universitaire Nantes Hotel Dieu

    RECRUITING

    Nantes, 44000, France

  • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

    RECRUITING

    Porto Alegre, 90110-270, Brazil

  • Chongqing Cancer Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, 400030, China

  • Chu de Poitiers Site de La Mileterie

    COMPLETED

    Poitiers, 86000, France

  • City of Hope Irvine Lennar

    RECRUITING

    Irvine, California, 92618-2377, United States

  • City of Hope National Medical Center

    RECRUITING

    Duarte, California, 91010-3012, United States

  • Cross Cancer Institute

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Emory University Winship Cancer Center

    RECRUITING

    Atlanta, Georgia, 30322-1013, United States

  • Fujian Medical University Union Hospital

    COMPLETED

    Fuzhou, Fujian, 350001, China

  • General Hospital of Athens Alexandra

    RECRUITING

    Athens, 115 28, Greece

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601-1915, United States

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • Hopital Claude Huriez Chu Lille

    RECRUITING

    Lille, 59000, France

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Sao Rafael (Rede Dor)

    RECRUITING

    Salvador, 41253-190, Brazil

  • Hospital Sirio Libanes

    RECRUITING

    São Paulo, 01308-050, Brazil

  • Hospital Sirio Libanes Brasilia

    RECRUITING

    Brasília, 70200-730, Brazil

  • Hunan Cancer Hospital

    COMPLETED

    Changsha, Hunan, 410013, China

  • Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112-5550, United States

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch

    RECRUITING

    Tianjin, Tianjin Municipality, 301617, China

  • Instituto Dor de Pesquisa E Ensino Distrito Federal

    RECRUITING

    Brasília, 70390140, Brazil

  • Instituto Dor de Pesquisa E Ensino Sao Paulo

    RECRUITING

    São Paulo, 01401-004, Brazil

  • Istituto Europeo Di Oncologia

    RECRUITING

    Milan, 20141, Italy

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

    RECRUITING

    Meldola, 47014, Italy

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Massachusetts General Hospital

    COMPLETED

    Boston, Massachusetts, 02114, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226-3522, United States

  • Memorial Sloan Kettering Cancer Center Mskcc

    RECRUITING

    New York, New York, 10065-6800, United States

  • Monash Health

    RECRUITING

    Clayton, Victoria, VIC 3168, Australia

  • National University Hospital Singapore

    RECRUITING

    Singapore, 119074, Singapore

  • Nepean Hospital

    RECRUITING

    Kingswood, New South Wales, NSW 2747, Australia

  • Oxford University Hospitals Nhs Trust Churchill Hospital

    RECRUITING

    Headington, OX3 7LE, United Kingdom

  • Peking University Peoples Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100044, China

  • Peking University Third Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100000, China

  • Policlinico Sorsola Malpighi, Aou Di Bologna

    RECRUITING

    Bologna, 40138, Italy

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Qingdao Municipal Hospital

    RECRUITING

    Qingdao, Shandong, 266000, China

  • Royal Cornwall Hospitalsnhs Trust

    RECRUITING

    Truro, TR1 3LJ, United Kingdom

  • Royal Marsden Nhs Foundation Royal Marsden Hospital

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • Royal Perth Hospital

    RECRUITING

    Perth, Western Australia, WA 6000, Australia

  • Samsung Medical Center

    RECRUITING

    GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    RECRUITING

    SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

  • Shanghai Fourth Peoples Hospital Affiliated to Tongji University

    COMPLETED

    Shanghai, Shanghai Municipality, 200434, China

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    RECRUITING

    São Paulo, 05652-900, Brazil

  • St Vincents Hospital Melbourne

    RECRUITING

    Fitzroy, Victoria, VIC 3065, Australia

  • Sun Yat Sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, VIC 3004, Australia

  • The Catholic University of Korea, Seoul St Marys Hospital

    RECRUITING

    SeochoGu, Seoul Teugbyeolsi, 06591, South Korea

  • The First Affiliated Hospital of Nanchang University Branch Xianghu

    RECRUITING

    Nanchang, Jiangxi, 332000, China

  • The First Affiliated Hospital of Xiamen University

    COMPLETED

    Xiamen, Fujian, 361003, China

  • The First Affiliated Hospital of Zhengzhou University

    ACTIVE_NOT_RECRUITING

    Zhengzhou, Henan, 450052, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110001, China

  • The James Cancer Hospital and Solove Research Institute At Ohio State University

    RECRUITING

    Columbus, Ohio, 43210-1240, United States

  • The Second Hospital of Hebei Medical University

    COMPLETED

    Shijiazhuang, Hebei, 050000, China

  • Tianjin Medical University General Hospital

    COMPLETED

    Tianjin, Tianjin Municipality, 300052, China

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Universitaetsklinikum Aachen

    RECRUITING

    Aachen, 52074, Germany

  • Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden

    RECRUITING

    Dresden, 01307, Germany

  • Universitatsklinikum Hamburg Eppendorf

    RECRUITING

    Hamburg, 20251, Germany

  • Universitatsklinikum Wurzburg

    RECRUITING

    Würzburg, 97080, Germany

  • University College Hospital

    RECRUITING

    London, NW1 2PG, United Kingdom

  • University Hospital of Alexandroupolis

    RECRUITING

    Alexandroupoli, 68100, Greece

  • University of Alabama At Birmingham Hospital

    RECRUITING

    Birmingham, Alabama, 35294-0004, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637-1443, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136-2107, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

  • University of Wisconsin Carbone Cancer Center

    RECRUITING

    Madison, Wisconsin, 53792-0001, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110-1010, United States

  • Weill Cornell Medical College Newyork Presbyterian Hospital

    RECRUITING

    New York, New York, 10065-4870, United States

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Other studies related to the condition(s) this trial covers.