An Investigational Study of BG-89894 Tablets in Participants With Advanced Solid Tumors

NCT ID: NCT06568614

Last Updated: 2026-02-05

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-12

Study Completion Date

2028-12-30

Brief Summary

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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 through the body, and whether it shows any early signs of helping to treat cancer. The information gathered may help guide how future studies are designed. The entire study is expected to last about four years. People who join the study may receive treatment for around six months and will be followed for about 12 months after their treatment ends. The study plans to enroll participants over a three-year period.

Detailed Description

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Conditions

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Advanced or Metastatic MTAP-deleted Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

BG-89894

Intervention Type DRUG

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).

Group Type EXPERIMENTAL

BG-89894

Intervention Type DRUG

Administered orally

Interventions

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BG-89894

Administered orally

Intervention Type DRUG

Other Intervention Names

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SYH2039

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BeOne Medicines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Columbia University Irving Medical Center

New York, New York, United States

Site Status RECRUITING

Next Virginia

Fairfax, Virginia, United States

Site Status RECRUITING

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia

Site Status RECRUITING

Cancer Research South Australia

Adelaide, South Australia, Australia

Site Status RECRUITING

St Vincents Hospital

Fitzroy, Victoria, Australia

Site Status RECRUITING

Linear Clinical Research

Nedlands, Western Australia, Australia

Site Status RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Guangdong Provincial Peoples Hospital Huifu Branch

Guangzhou, Guangdong, China

Site Status RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Site Status RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status RECRUITING

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

The First Hospital of China Medical University Hunnan Branch

Shenyang, Liaoning, China

Site Status RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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United States Australia China

Central Contacts

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Study Director

Role: CONTACT

1.877.828.5568

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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