RecruitingPhase 1NCT06589596

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

A Phase 1a/b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of PRMT5 Inhibitor BGB-58067 Alone and in Combination With Anticancer Agents in Patients With Advanced Solid Tumors

Sponsor

BeOne Medicines

Enrollment

525 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BG-89894, a drug called BGB-58067, and others for people with advanced solid tumor. The study is currently recruiting participants at 92 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBGB-58067

Planned doses administered on specified days per protocol.

DRUGBG-89894

Planned doses administered on specified days per protocol.

DRUGStandard of Care Therapy

Administered in accordance with relevant local guidelines and/or prescribing information.

Locations(101)

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

Usc Norris Comprehensive Cancer Center (Nccc)

Los Angeles, California, United States

Adventhealth

Celebration, Florida, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Nyu Langone Health

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

Tennessee Oncology, Pllc Nashville

Nashville, Tennessee, United States

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States

Next Oncology Dallas

Irving, Texas, United States

Next Oncology Virginia

Fairfax, Virginia, United States

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Monash Health

Clayton, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

Fundacao Pio Xii Hospital de Amor de Barretos

Barretos, Brazil

Fundacao Universidade de Caxias Do Sul

Caxias do Sul, Brazil

Liga Norte Riograndene Contra O Cancer

Natal, Brazil

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, Brazil

Hospital Sao Lucas Da Pucrs

Porto Alegre, Brazil

Ensino E Terapia de Inovacao Clinica Amo Etica

Salvador, Brazil

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

São Paulo, Brazil

Nucleo de Pesquisa E Ensino Da Rede Sao Camilo

São Paulo, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil

Hospital Santa Rita de Cassia Afecc

Vitória, Brazil

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

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

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Meizhou People Hospital

Meizhou, Guangdong, China

Guangxi Medical University Cancer Hospital Wuxiang Branch

Nanning, Guangxi, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 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

Hubei Cancer Hospital

Wuhan, Hubei, China

Yichang Central Peoples Hospital

Yichang, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Jinan Central Hospital

Jinan, Shandong, China

Shandong Cancer Hospital

Jinan, Shandong, China

The Second Affiliated Hospital of Shandong First Medical University

Taian, Shandong, China

Weifang Peoples Hospital Beichen Branch

Weifang, Shandong, China

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine