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ACTIVE NOT RECRUITING
NCT05471843
PHASE1/PHASE2

Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma

Sponsor: BeiGene

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

125

Start Date

2022-09-05

Completion Date

2027-01-31

Last Updated

2025-09-09

Healthy Volunteers

No

Interventions

DRUG

BGB-11417

Administered orally

Locations (104)

University of Alabama At Birmingham Hospital

Birmingham, Alabama, United States

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

Des Moines Oncology Research Association

Des Moines, Iowa, United States

Tulane Cancer Center

New Orleans, Louisiana, United States

Luminis Health Anne Arundel Medical Center

Annapolis, Maryland, United States

Maryland Oncology Hematology, Pa

Columbia, Maryland, United States

University of Missouri Hospital, Ellis Fischel Cancer Center

Columbia, Missouri, United States

Nebraska Cancer Specialists

Grand Island, Nebraska, United States

Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Novant Health Hematology Charlotte

Charlotte, North Carolina, United States

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States

Hospital Aleman

Buenos Aires, Argentina

Az Sint Jan Brugge

Bruges, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

University Hospitals Leuven

Leuven, Belgium

AZ DELTA

Roeselare, Belgium

Hospital Erasto Gaertner

Curitiba, Brazil

Hospital Mae de Deus

Porto Alegre, Brazil

Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp

Ribeirão Preto, Brazil

Oncoclinicas Rio de Janeiro Sa

Rio de Janeiro, Brazil

Instituto Americas Ensino, Pesquisa E Inovacao

Rio de Janeiro, Brazil

Hospital Sao Rafael (Rede Dor)

Salvador, Brazil

Hospital Beneficencia Portuguesa de Sao Paulo

São Paulo, Brazil

Instituto Dor de Pesquisa E Ensino Sao Paulo

São Paulo, Brazil

Accamargo Cancer Center

São Paulo, Brazil

Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular

São Paulo, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil

Qeii Health Science Center

Halifax, Nova Scotia, Canada

Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital

Hefei, Anhui, China

China Japan Friendship Hospital

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University(Tongzhou)

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, China

Guangdong Provincial Peoples Hospital Huifu Branch

Guangzhou, Guangdong, China

Jiangmen Central Hospital

Jiangmen, Guangdong, China

The Tumor Hospital Affiliated to Guangxi Medical University

Nanning, Guangxi, China

Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Hainan General Hospital

Haikou, Hainan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

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

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi, China

Jiangxi Province Cancer Hospital

Nanchang, Jiangxi, China

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Shandong Cancer Hospital

Jinan, Shandong, China

The Affiliated Hospital of Qingdao University Branch West Coast

Qingdao, Shandong, China

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Institute of Hematology and Hospital of Blood Disease

Tianjin, Tianjin Municipality, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

The First Peoples Hospital of Kashgar

Kashgar, Xinjiang, China

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Centre Hospitalier Le Mans

Le Mans, France

Centre Hospitalier Universitaire Nantes Hotel Dieu

Nantes, France

Hopital Pitie Salpetriere Service Hematologie

Paris, France

Necker University Hospital

Paris, France

Chu Hopital Lyon Sud

PierreBenite, France

Chu Tours Hopital Bretonneau Service Pneumologie

Tours, France

Universitatsklinikum Koln, Innere Medizin I

Cologne, Germany

Universitatsklinikum Dusseldorf

Düsseldorf, Germany

Universitatsklinikum Essen (Aor)

Essen, Germany

Universitatsklinikum Schleswig Holstein, Campus Kiel

Kiel, Germany

Assuta Ashdod Medical Center

Ashdod, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Hadassah En Karem Medical Center

Jerusalem, Israel

Rabin Medical Center

Petah Tikva, Israel

Sheba Medical Center

Tel Aviv, Israel

Sourasky Tel Aviv Medical Center

Tel Aviv, Israel

Irccs Istituto Tumori Giovanni Paolo Ii

Bari, Italy

Policlinico Sorsola Malpighi, Aou Di Bologna

Bologna, Italy

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Brescia, Italy

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

Meldola, Italy

Aou Maggiore Della Carita

Novara, Italy

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Pratia McM Krakow

Krakow, Poland

Uniwersytecki Szpital Kliniczny Nr W Lublinie

Lublin, Poland

Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy

Warsaw, Poland

Auxilio Mutuo Cancer Center

San Juan, Puerto Rico

Hospital Universitario Vall Dhebron

Barcelona, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Ankara University Medical Faculty

Ankara, Turkey (Türkiye)

Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

Ankara, Turkey (Türkiye)

Gazi University

Ankara, Turkey (Türkiye)

Ondokuz Mayis University Medicine Faculty Hospital

Atakum Samsun, Turkey (Türkiye)

Bagcilar Medipol Mega Hospital

Istanbul, Turkey (Türkiye)

Vkv American Hospital

Istanbul, Turkey (Türkiye)

Ege University Medical Faculty

Izmir, Turkey (Türkiye)

Erciyes University School of Medicine

Kayseri, Turkey (Türkiye)

Kocaeli Universitesi Tip Fakultesi

Kocaeli, Turkey (Türkiye)

The Christie Hospital

Greater Manchester, United Kingdom

Churchill Hospital Oxford University Hospital Nhs Trust

Headington, United Kingdom

University College Hospital

London, United Kingdom

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, United Kingdom