An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors
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
Interventions
BGB-58067
BG-89894
Standard of Care Therapy
Conditions
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