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RECRUITING
NCT06589596
PHASE1

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

Sponsor: BeOne Medicines

View on ClinicalTrials.gov

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, and in combination with standard of care therapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

244

Start Date

2024-10-11

Completion Date

2029-01

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

DRUG

BGB-58067

Planned doses administered on specified days per protocol.

DRUG

BG-89894

Planned doses administered on specified days per protocol.

DRUG

Standard of Care Therapy

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

Locations (62)

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

Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States

Next Dallas

Irving, Texas, United States

Next 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

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

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 University of Chinese Medicine

Guangzhou, Guangdong, China

Guangxi Medical University Cancer Hospital Wuxiang Branch

Nanning, Guangxi, 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

Jiangsu Province Hospital

Nanjing, Jiangsu, 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

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

Shanghai, Shanghai Municipality, China

Shanghai East Hospital Branch Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Centerpudong

Shanghai, Shanghai Municipality, China

Sichuan Cancer Hospitaltianfu Branch

Chengdu, Sichuan, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Deyangs People Hospital

Deyang, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Provincial Peoples Hospital

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang

Taizhou, Zhejiang, China

Rigshospitalet

Copenhagen, Denmark

Centre de Lutte Contre Le Cancer Institut Bergonie

Bordeaux, France

Institut Curie Paris

Paris, France

Institut de Cancerologie de Louest

Saint-Herblain, France

Institut Gustave Roussy

Villejuif, France

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Samsung Medical Center

GangnamGu, 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 Universitario Vall Dhebron

Barcelona, Spain

Start Madrid Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario Hm Madrid Sanchinarro

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain