Status:
RECRUITING
An Investigational Study of BG-89894 Tablets in Participants With Advanced Solid Tumors
Lead Sponsor:
BeOne Medicines
Conditions:
Advanced or Metastatic MTAP-deleted Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is being done to learn more about a new drug called BG-89894 (previously known as SYH2039). Researchers want to see if the drug is safe, how well people can tolerate it, how it moves throug...
Eligibility Criteria
Inclusion
- Key
- Must sign a written informed consent and willing to comply with all study-related procedures and requirements.
- 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.
- Key
Exclusion
- History of other malignancies or concurrent active malignancies within 3 years.
- 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.
Key Trial Info
Start Date :
October 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06568614
Start Date
October 12 2024
End Date
December 30 2028
Last Update
June 11 2025
Active Locations (3)
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1
Guangdong Provincial Peoples Hospital Huifu Branch
Guangzhou, Guangdong, China, 510120
2
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050011
3
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060