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
3 other identifiers
interventional
525
11 countries
98
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2025
Typical duration for phase_1
98 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
January 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
July 22, 2026
July 1, 2026
2.7 years
September 6, 2024
July 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Phase 1a: Number of Participants with Adverse Events and Serious Adverse Events
Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), and laboratory assessments.
From first dose of the study drug(s) to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 13 months)
Phase 1a: Number of Participants with Adverse Events that meet Dose-Limiting Toxicity (DLT) criteria
Approximately 1 month
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached. Note: BGB-58067 + BG-89894 combination has been discontinued.
Approximately 1 month
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy
RDFE of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy will be determined based upon the MTD or MAD. Note: BGB-58067 + BG-89894 combination has been discontinued.
Approximately 13 months
Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-58067 alone and in combination with standard of care therapy
RP2D established from Phase 1a for BGB-58067 alone and in combination with standard of care therapy for administration in selected tumor types.
Approximately 2 years
Phase 1b: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR), as assessed by the investigator.
Approximately 2 years
Secondary Outcomes (14)
Phase 1a: Objective Response Rate (ORR)
Approximately 2 years
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BGB-58067
Approximately 2 months
Phase 1a and 1b: Minimum observed plasma concentration (Cmin) of BGB-58067
Approximately 9 months
Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BGB-58067
Approximately 2 months
Phase 1a and 1b: Apparent oral clearance (CL/F) for BGB-58067
Approximately 2 months
- +9 more secondary outcomes
Study Arms (4)
Phase 1a: BGB-58067 Monotherapy Dose Escalation and Safety Expansion
EXPERIMENTALSequential cohorts of increasing dose levels of BGB-58067 as monotherapy will be evaluated.
Phase 1a: BGB-58067 + BG-89894 Combination Therapy Dose Escalation
EXPERIMENTALSequential cohorts of increasing dose levels of BGB-58067 in combination with BG-89894 will be evaluated. Enrollment in this combination has been discontinued.
Phase 1a: BGB-58067 + Standard of Care Combination Therapy Dose Escalation
EXPERIMENTALSequential cohorts of increasing dose levels of BGB-58067 in combination with standard of care therapy will be evaluated.
Phase 1b: Dose Expansion and Optimization
EXPERIMENTALRecommended Dose(s) for Expansion (RDFE\[s\]) of BGB-58067 alone and in combination with standard of care therapy will be evaluated for selected indications and regimen(s) based on emerging data.
Interventions
Planned doses administered on specified days per protocol.
Administered in accordance with relevant local guidelines and/or prescribing information.
Planned doses administered on specified days per protocol.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeOne Medicineslead
Study Sites (98)
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
SĂ£o Paulo, 01246-000, Brazil
Nucleo de Pesquisa E Ensino Da Rede Sao Camilo
SĂ£o Paulo, 04014-002, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
SĂ£o 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
Study Officials
- STUDY DIRECTOR
Study Director
BeOne Medicines
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2024
First Posted
September 19, 2024
Study Start
January 10, 2025
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
July 22, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.