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NCT06589596PHASE1Recruiting

An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors

BeOne Medicines

Start Date

1/10/2025

Completion Date

9/30/2027

Summary

This is an open-label, multicenter, first-in-human dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-58067 alone, in combination with BG-89894 (discontinued), and in combination with standard of care therapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.

Detailed Description

BGB-58067 is a new drug designed to target a specific protein called protein arginine methyltransferase 5 (PRMT5). This protein is involved in many cell activities and can promote cancer growth when it is overactive. High levels of PRMT5 are linked to poor outcomes in several types of cancer. This new study will check how safe and helpful a potential anticancer drug called BGB-58067 is. This drug will be tested alone, in combination with BG-89894 (discontinued), and in combination with standard of care therapy in participants with advanced solid tumors and with MTAP deficiency. Note: 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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Participants must sign the ICF and be capable of giving written informed consent * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Scale (KPS) ≥ 70 * Life expectancy ≥ 3 months * Evidence of homozygous loss of MTAP or lost MTAP expression in the tumor tissue * Able to provide tumor sample to meet the minimum tissue requirement for central MTAP deficiency testing * Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose diseases have progressed or recurred after receiving standard systemic therapy or radiotherapy, or for whom standard systemic therapy is not available or tolerated, or would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard treatment in the opinion of the investigator; participants with advanced, metastatic, or unresectable solid tumors who have not received prior systemic treatment or have received one cycle of standard-of-care therapies will be enrolled in selected cohorts * Adequate organ function Exclusion Criteria: * Prior treatment with any methylthioadenosine (MTA)-cooperative PRMT5 inhibitor or methionine adenosyltransferase 2a (MAT2A) inhibitor * Active leptomeningeal disease or symptomatic spinal cord compression * Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage * Any malignancy ≤ 2 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively * Significantly impaired pulmonary function * Clinically significant infections * Serologically active hepatitis B or C infection * Known HIV infection. Participants with treated HIV infection may be included in Phase 1b if they meet certain criteria * High cardiovascular risk factors * QTcF \> 470 ms based on the screening triplicate 12-lead ECG records and/or a history of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, or a family history of Long QT Syndrome) * Toxicities (because of prior anticancer therapy) that have not recovered to baseline or stabilized * Participants who are unable to swallow or with disease/procedure significantly affecting gastrointestinal function * Female participants who are pregnant or are breastfeeding * Concurrent participation in another therapeutic clinical study (participation in observational or noninterventional studies is allowed) Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

BGB-58067

DRUG

BG-89894

DRUG

Standard of Care Therapy

Interested in This Trial?

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Conditions

Advanced Solid Tumor

Locations

Usc Norris Comprehensive Cancer Center (Nccc)

Los Angeles, California 90089-1019

United States

Adventhealth

Celebration, Florida 34747-4606

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215-5418

United States

Washington University School of Medicine

St Louis, Missouri 63110-1010

United States

Nyu Langone Health

New York, New York 10016-2708

United States

Columbia University Medical Center

New York, New York 10032

United States

Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania 19107-4307

United States

Tennessee Oncology, Pllc Nashville

Nashville, Tennessee 37203

United States

The University of Texas Md Anderson Cancer Center

Houston, Texas 77030-4009

United States

Next Dallas

Irving, Texas 75039-2743

United States

Next Virginia

Fairfax, Virginia 22031

United States

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales NSW 2148

Australia

Princess Alexandra Hospital

Woolloongabba, Queensland QLD 4102

Australia

Monash Health

Clayton, Victoria VIC 3168

Australia

Austin Health

Heidelberg, Victoria VIC 3084

Australia

Linear Clinical Research

Nedlands, Western Australia WA 6009

Australia

Fundacao Pio Xii Hospital de Amor de Barretos

Barretos, 14.784-400

Brazil

Fundacao Universidade de Caxias Do Sul

Caxias do Sul, 95070-560

Brazil

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, 90110-270

Brazil

Hospital Sao Lucas Da Pucrs

Porto Alegre, 90610-000

Brazil

Ensino E Terapia de Inovacao Clinica Amo Etica

Salvador, 41950-640

Brazil

Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

São Paulo, 01246-000

Brazil

Nucleo de Pesquisa E Ensino Da Rede Sao Camilo

São Paulo, 04014-002

Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, 05652-900

Brazil

The Second Hospital of Anhui Medical University

Hefei, Anhui 230601

China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality 100021

China

Beijing Cancer Hospital

Beijing, Beijing Municipality 100142

China

Peking Union Medical College Hospital

Beijing, Beijing Municipality 100730

China

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality 101149

China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality 400030

China

Fujian Cancer Hospital

Fuzhou, Fujian 350014

China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian 361003

China

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong 510060

China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong 510120

China

Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)

Guangzhou, Guangdong 510245

China

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong 510405

China

Meizhou People Hospital

Meizhou, Guangdong 514031

China

Guangxi Medical University Cancer Hospital Wuxiang Branch

Nanning, Guangxi 530201

China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei 050011

China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang 150000

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

Hubei Cancer Hospital

Wuhan, Hubei 430079

China

Yichang Central Peoples Hospital

Yichang, Hubei 443003

China

Hunan Cancer Hospital

Changsha, Hunan 410013

China

Jiangsu Province Hospital

Nanjing, Jiangsu 210029

China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi 330006

China

Jiangxi Cancer Hospital

Nanchang, Jiangxi 330029

China

The First Hospital of Jilin University

Changchun, Jilin 130021

China

The First Hospital of China Medical University

Shenyang, Liaoning 110001

China

Jinan Central Hospital

Jinan, Shandong 250013

China

Shandong Cancer Hospital

Jinan, Shandong 250117

China

The Second Affiliated Hospital of Shandong First Medical University

Taian, Shandong 271099

China

Weifang Peoples Hospital Beichen Branch

Weifang, Shandong 261057

China

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality 200025

China

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality 200040

China

Shanghai East Hospital Branch Hospital

Shanghai, Shanghai Municipality 200123

China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality 200433

China

Fudan University Shanghai Cancer Centerpudong

Shanghai, Shanghai Municipality 201321

China

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi 030013

China

Sichuan Cancer Hospitaltianfu Branch

Chengdu, Sichuan 610000

China

Sichuan Cancer Hospital and Institute

Chengdu, Sichuan 610041

China

West China Hospital, Sichuan University

Chengdu, Sichuan 610041

China

Deyangs People Hospital

Deyang, Sichuan 618000

China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality 300060

China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang 310003

China

Zhejiang Provincial Peoples Hospital

Hangzhou, Zhejiang 310014

China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang 310022

China

Taizhou Hospital of Zhejiang Provinceenze Branch

Taizhou, Zhejiang 318050

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang 325000

China

Rigshospitalet

Copenhagen, 2100

Denmark

Centre de Lutte Contre Le Cancer Institut Bergonie

Bordeaux, 33000

France

Institut Paoli Calmettes

Marseille, 13009

France

Institut Curie Paris

Paris, 75005

France

Institut de Cancerologie de Louest

Saint-Herblain, 44800

France

Institut Gustave Roussy

Villejuif, 94800

France

Hospital Pulau Pinang

George Town, 10990

Malaysia

Hospital Raja Perempuan Zainab Ii

Johor Bahru, 15586

Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, 50586

Malaysia

University Malaya Medical Centre

Kuala Lumpur, 59100

Malaysia

Sarawak General Hospital

Kuching, 93586

Malaysia

The Institute of Oncology, Arensia Exploratory Medicine

Chisinau, 2025

Moldova

The Catholic University of Korea, St Vincents Hospital

PaldalGu SuwonSi, Gyeonggi-do 16247

South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 13620

South Korea

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi 06351

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 Universitario Vall Dhebron

Barcelona, 08035

Spain

Start Madrid Fundacion Jimenez Diaz

Madrid, 28040

Spain

Hospital Universitario Hm Madrid Sanchinarro

Madrid, 28050

Spain

Hospital Clinico San Carlos

Madrid, 28240

Spain

Ramathibodi Hospital Mahidol University

Bangkok, 10400

Thailand

Siriraj Hospital

Bangkok, 10700

Thailand

Songklanagarind Hospital (Prince of Songkhla University)

Hat Yai, 90110

Thailand

Srinagarind Hospital (Khon Kaen University)

Muang, 40002

Thailand

Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)

Muang, 50200

Thailand