An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors
NCT ID: NCT06589596
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
237 participants
INTERVENTIONAL
2024-10-11
2027-06-30
Brief Summary
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Detailed Description
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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, and in combination with standard of care therapy in participants with advanced solid tumors and with MTAP deficiency.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1a: BGB-58067 Monotherapy Dose Escalation and Safety Expansion
Sequential cohorts of increasing dose levels of BGB-58067 as monotherapy will be evaluated.
BGB-58067
Planned doses administered on specified days per protocol.
Phase 1a: BGB-58067 + BG-89894 Combination Therapy Dose Escalation
Sequential cohorts of increasing dose levels of BGB-58067 in combination with BGB-89894 will be evaluated.
BGB-58067
Planned doses administered on specified days per protocol.
BG-89894
Planned doses administered on specified days per protocol.
Phase 1a: BGB-58067 + Standard of Care Combination Therapy Dose Escalation
Sequential cohorts of increasing dose levels of BGB-58067 in combination with standard of care therapy will be evaluated.
BGB-58067
Planned doses administered on specified days per protocol.
Standard of Care Therapy
Administered in accordance with relevant local guidelines and/or prescribing information.
Phase 1b: Dose Expansion and Optimization
Recommended Dose(s) for Expansion (RDFE\[s\]) of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy will be evaluated for selected indications and regimen(s) based on emerging data.
BGB-58067
Planned doses administered on specified days per protocol.
BG-89894
Planned doses administered on specified days per protocol.
Standard of Care Therapy
Administered in accordance with relevant local guidelines and/or prescribing information.
Interventions
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BGB-58067
Planned doses administered on specified days per protocol.
BG-89894
Planned doses administered on specified days per protocol.
Standard of Care Therapy
Administered in accordance with relevant local guidelines and/or prescribing information.
Eligibility Criteria
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Inclusion Criteria
* 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
* Adequate organ function
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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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
Monash Health
Clayton, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 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
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
The First Hospital of China Medical University
Shenyang, Liaoning, 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
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Rigshospitalet
Copenhagen, , Denmark
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, , France
Institut Curie Paris
Paris, , France
Institut Gustave Roussy
Villejuif, , France
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
Hospital Clinico San Carlos
Madrid, , Spain
Start Madrid Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario Hm Madrid Sanchinarro
Madrid, , Spain
Countries
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Central Contacts
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Other Identifiers
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2024-515307-19-00
Identifier Type: CTIS
Identifier Source: secondary_id
CTR20244451
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-58067-101
Identifier Type: -
Identifier Source: org_study_id