An Investigational Study of BG-89894 Tablets in Participants With Advanced Solid Tumors
NCT ID: NCT06568614
Last Updated: 2026-02-05
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
140 participants
INTERVENTIONAL
2024-10-12
2028-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase 1a: Dose Escalation and Safety Expansion
Sequential cohorts of increasing dose levels of BG-89894 (SYH2039) will be evaluated as monotherapy.
BG-89894
Administered orally
Phase 1b: Dose Expansion and Optimization
Multiple indication-specific cohorts will be evaluated for safety, tolerability, and potential dose optimization of BG-89894 (SYH2039).
BG-89894
Administered orally
Interventions
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BG-89894
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years (or the legal age of consent according to local regulations).
* Histologically or cytologically confirmed diagnosis of advanced, metastatic, or unresectable solid tumors that have progressed on or after standard therapy, or for which no appropriate standard therapy is available.
* Evidence of Methylthioadenosine phosphorylase (MTAP) homozygous deletion or loss of MTAP expression in tumor tissue.
* Participants must be able to provide an archived tumor tissue sample or unstained fresh biopsy if there is no archival tissue at baseline.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and evidence of adequate organ function and bone marrow reserve, as defined in the study protocol.
Exclusion Criteria
* Prior treatment with methionine adenosyltransferase 2 alpha (MAT2A) inhibitors (e.g., AG-270, IDE397) or methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitors (e.g., AMG193).
* Uncontrolled or active central nervous system (CNS) disease, including untreated or symptomatic brain metastases, spinal cord compression, or leptomeningeal carcinomatosis.
* Active bleeding, history of major bleeding events within the past 6 months, or tumors associated with a high risk of vascular invasion.
* Receipt of systemic anticancer therapy, radiation therapy, live vaccine, or major surgical procedures within protocol-specified washout periods.
* Active or uncontrolled infections, including tuberculosis (TB), (COVID-19, known human immunodeficiency virus (HIV) infection, or uncontrolled hepatitis B virus (HBV) infection.
Note: Additional eligibility criteria may apply.
18 Years
ALL
No
Sponsors
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BeOne Medicines
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeOne Medicines
Locations
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Sidney Kimmel Comprehensive Cancer At Johns Hopkins
Baltimore, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
Columbia University Irving Medical Center
New York, New York, United States
Next Virginia
Fairfax, Virginia, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Cancer Research South Australia
Adelaide, South Australia, Australia
St Vincents Hospital
Fitzroy, 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
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Guangdong Provincial Peoples Hospital Huifu Branch
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Hospital of China Medical University Hunnan Branch
Shenyang, Liaoning, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Other Identifiers
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SYH2039-001
Identifier Type: OTHER
Identifier Source: secondary_id
CTR20242626
Identifier Type: REGISTRY
Identifier Source: secondary_id
BG-89894-101
Identifier Type: -
Identifier Source: org_study_id
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