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NCT04973605

PHASE1/PHASE2

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

Sponsor: BeOne Medicines

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

246

Start Date

2021-09-16

Completion Date

2026-11

Last Updated

2026-03-19

Healthy Volunteers

Conditions

Relapsed/Refractory Multiple Myeloma

Interventions

DRUG

Sonrotoclax

Administered orally daily

DRUG

Dexamethasone

Once weekly either orally or intravenously

DRUG

Carfilzomib

Administered intravenously weekly

DRUG

Daratumumab

Administered subcutaneously weekly

DRUG

Pomalidomide

Administered orally daily

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.

Locations (83)

University of Alabama At Birmingham Hospital

Birmingham, Alabama, United States

City of Hope National Medical Center

Duarte, California, United States

City of Hope Irvine Lennar

Irvine, California, United States

University of California At San Francisco

San Francisco, California, United States

University of Miami

Miami, Florida, United States

Emory University Winship Cancer Center

Atlanta, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Weill Cornell Medical College Newyork Presbyterian Hospital

New York, New York, United States

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, United States

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

Columbus, Ohio, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

University of Washington

Seattle, Washington, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Canberra Hospital

Garran, Australian Capital Territory, Australia

Nepean Hospital

Kingswood, New South Wales, Australia

Monash Health

Clayton, Victoria, Australia

St Vincents Hospital Melbourne

Fitzroy, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Hospital Sirio Libanes Brasilia

Brasília, Brazil

Instituto Dor de Pesquisa E Ensino Distrito Federal

Brasília, Brazil

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, Brazil

Hospital Sao Rafael (Rede Dor)

Salvador, Brazil

Hospital Sirio Libanes

São Paulo, Brazil

Instituto Dor de Pesquisa E Ensino Sao Paulo

São Paulo, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil

Cross Cancer Institute

Edmonton, Alberta, Canada

British Columbia Cancer Agency the Vancouver Centre

Vancouver, British Columbia, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Peking University Third Hospital

Beijing, Beijing Municipality, China

Beijing Chao Yang Hospital

Beijing, Beijing Municipality, China

Peking University Peoples Hospital

Beijing, Beijing Municipality, China

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

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

Wuhan, Hubei, China

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanchang University Branch Xianghu

Nanchang, Jiangxi, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Qingdao Municipal Hospital

Qingdao, Shandong, China

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Shanghai Fourth Peoples Hospital Affiliated to Tongji University

Shanghai, Shanghai Municipality, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

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

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Universitaetsklinikum Aachen

Aachen, Germany

Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden

Dresden, Germany

Universitatsklinikum Hamburg Eppendorf

Hamburg, Germany

Universitatsklinikum Wurzburg

Würzburg, Germany

University Hospital of Alexandroupolis

Alexandroupoli, Greece

General Hospital of Athens Alexandra

Athens, Greece

Azienda Ospedaliera Policlinico Di Bari

Bari, Italy

Policlinico Sorsola Malpighi, Aou Di Bologna

Bologna, Italy

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

Meldola, Italy

Istituto Europeo Di Oncologia

Milan, Italy

Istituto Di Candiolo Irccs

Torino, Italy

Azienda Ospedaliera Universitaria Delle Marche

Torrette, Italy

National University Hospital Singapore

Singapore, Singapore

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital San Pedro de Alcantara

Cáceres, Spain

Hospital Universitario Virgen de La Victoria

Málaga, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Oxford University Hospitals Nhs Trust Churchill Hospital

Headington, United Kingdom

University College Hospital

London, United Kingdom

Royal Marsden Nhs Foundation Royal Marsden Hospital

Sutton, United Kingdom

Royal Cornwall Hospitalsnhs Trust

Truro, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (83)