What this study is
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), in combination with standard of care therapy, and in combination with novel anticancer therapies in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.
What's being tested
- BGB-58067
Intervention · DRUG
- BG-89894
Intervention · DRUG
- Standard of Care Therapy
Intervention · DRUG
Administered in accordance with relevant local guidelines and/or prescribing information.
- RAS(ON) Inhibitors
Intervention · DRUG
All of BGB-58067, BG-89894, RAS(ON) Inhibitors
Planned doses administered on specified days per protocol.
Study details
- 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
- Sponsor
- BeOne Medicines
- Conditions
- Advanced Solid Tumor
- Enrolling
- 695 people
- Starts
- 2025-01-10
- Est. completion
- 2028-08-31
- Design
- Open-label, non-randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Participants must sign the Informed Consent Form 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; documented RAS mutation status or KRAS mutation is required for selected cohorts
- 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
You can't join if
- Prior treatment with any 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 human immunodeficiency virus (HIV) infection. Participants with treated HIV infection may be included in Phase 1b if they meet certain criteria
- High cardiovascular risk factors
- QT interval corrected by Fridericia's method (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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (101)
101 openCancer and Blood Specialty Clinic
Los Alamitos, California, United States
RecruitingUsc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, United States
RecruitingAdventhealth
Celebration, Florida, United States
RecruitingDana Farber Cancer Institute
Boston, Massachusetts, United States
RecruitingWashington University School of Medicine
St Louis, Missouri, United States
RecruitingNyu Langone Health
New York, New York, United States
RecruitingColumbia University Medical Center
New York, New York, United States
RecruitingSidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
RecruitingTennessee Oncology, Pllc Nashville
Nashville, Tennessee, United States
RecruitingThe University of Texas Md Anderson Cancer Center
Houston, Texas, United States
RecruitingNext Oncology Dallas
Irving, Texas, United States
RecruitingNext Oncology Virginia
Fairfax, Virginia, United States
Recruiting
89 sites outside the US
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
RecruitingPrincess Alexandra Hospital
Woolloongabba, Queensland, Australia
RecruitingMonash Health
Clayton, Victoria, Australia
RecruitingAustin Health
Heidelberg, Victoria, Australia
RecruitingLinear Clinical Research
Nedlands, Western Australia, Australia
RecruitingFundacao Pio Xii Hospital de Amor de Barretos
Barretos, Brazil
RecruitingFundacao Universidade de Caxias Do Sul
Caxias do Sul, Brazil
RecruitingLiga Norte Riograndene Contra O Cancer
Natal, Brazil
RecruitingCentro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, Brazil
RecruitingHospital Sao Lucas Da Pucrs
Porto Alegre, Brazil
RecruitingEnsino E Terapia de Inovacao Clinica Amo Etica
Salvador, Brazil
RecruitingIcesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo, Brazil
RecruitingNucleo de Pesquisa E Ensino Da Rede Sao Camilo
São Paulo, Brazil
RecruitingSociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil
RecruitingHospital Santa Rita de Cassia Afecc
Vitória, Brazil
RecruitingThe Second Hospital of Anhui Medical University
Hefei, Anhui, China
RecruitingCancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RecruitingBeijing Cancer Hospital
Beijing, Beijing Municipality, China
RecruitingPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
RecruitingBeijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RecruitingChongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
RecruitingFujian Cancer Hospital
Fuzhou, Fujian, China
RecruitingThe First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
RecruitingSun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
RecruitingThe First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RecruitingSun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong, China
RecruitingThe First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
RecruitingMeizhou People Hospital
Meizhou, Guangdong, China
RecruitingGuangxi Medical University Cancer Hospital Wuxiang Branch
Nanning, Guangxi, China
RecruitingThe Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RecruitingHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RecruitingHenan Cancer Hospital
Zhengzhou, Henan, China
RecruitingThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RecruitingUnion Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RecruitingHubei Cancer Hospital
Wuhan, Hubei, China
RecruitingYichang Central Peoples Hospital
Yichang, Hubei, China
RecruitingHunan Cancer Hospital
Changsha, Hunan, China
RecruitingJiangsu Province Hospital
Nanjing, Jiangsu, China
RecruitingThe Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
RecruitingJiangxi Cancer Hospital
Nanchang, Jiangxi, China
RecruitingThe First Hospital of Jilin University
Changchun, Jilin, China
RecruitingThe First Hospital of China Medical University
Shenyang, Liaoning, China
RecruitingJinan Central Hospital
Jinan, Shandong, China
RecruitingShandong Cancer Hospital
Jinan, Shandong, China
RecruitingThe Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong, China
RecruitingWeifang Peoples Hospital Beichen Branch
Weifang, Shandong, China
RecruitingRui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RecruitingHuashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
RecruitingShanghai East Hospital Branch Hospital
Shanghai, Shanghai Municipality, China
RecruitingShanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
RecruitingFudan University Shanghai Cancer Centerpudong
Shanghai, Shanghai Municipality, China
RecruitingShanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
RecruitingSichuan Cancer Hospitaltianfu Branch
Chengdu, Sichuan, China
RecruitingSichuan Cancer Hospital and Institute
Chengdu, Sichuan, China
RecruitingWest China Hospital, Sichuan University
Chengdu, Sichuan, China
RecruitingDeyangs People Hospital
Deyang, Sichuan, China
RecruitingTianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RecruitingThe First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RecruitingZhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang, China
RecruitingZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RecruitingTaizhou Hospital of Zhejiang Provinceenze Branch
Taizhou, Zhejiang, China
RecruitingThe First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
RecruitingRigshospitalet
Copenhagen, Denmark
RecruitingCentre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, France
RecruitingInstitut Paoli Calmettes
Marseille, France
RecruitingInstitut Curie Paris
Paris, France
RecruitingInstitut de Cancerologie de Louest
Saint-Herblain, France
RecruitingInstitut Gustave Roussy
Villejuif, France
RecruitingHospital Pulau Pinang
George Town, Malaysia
RecruitingHospital Raja Perempuan Zainab Ii
Johor Bahru, Malaysia
RecruitingHospital Kuala Lumpur
Kuala Lumpur, Malaysia
RecruitingUniversity Malaya Medical Centre
Kuala Lumpur, Malaysia
RecruitingSarawak General Hospital
Kuching, Malaysia
RecruitingThe Institute of Oncology, Arensia Exploratory Medicine
Chisinau, Moldova
RecruitingThe Catholic University of Korea, St Vincents Hospital
PaldalGu SuwonSi, Gyeonggi-do, South Korea
RecruitingSeoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
RecruitingSamsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea
RecruitingSeverance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea
RecruitingSeoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
RecruitingAsan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea
RecruitingHospital Universitario Vall Dhebron
Barcelona, Spain
RecruitingStart Madrid Fundacion Jimenez Diaz
Madrid, Spain
RecruitingHospital Universitario Hm Madrid Sanchinarro
Madrid, Spain
RecruitingHospital Clinico San Carlos
Madrid, Spain
RecruitingRamathibodi Hospital Mahidol University
Bangkok, Thailand
RecruitingSiriraj Hospital
Bangkok, Thailand
RecruitingSongklanagarind Hospital (Prince of Songkhla University)
Hat Yai, Thailand
RecruitingSrinagarind Hospital (Khon Kaen University)
Muang, Thailand
RecruitingMaharaj Nakorn Chiang Mai Hospital (Chiang Mai University)
Muang, Thailand
Recruiting
Study team
Sponsor
BeOne Medicines
Study ID BGB-58067-101
Study director
Study Director
BeOne Medicines
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.