Advanced or Metastatic MTAP-deleted Solid TumorsPhase 1NCT06568614
An Investigational Study of BG-89894 Tablets in Participants With Advanced Solid Tumors
A Phase 1 study testing BG-89894 in people with Advanced or Metastatic MTAP-deleted Solid Tumors, run by BeOne Medicines at 20 sites in 3 countries.
Trial 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 through the body, and whether it shows any early signs of helping to treat cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic MTAP-deleted Solid Tumors
- What is being tested?
- BG-89894
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 12 Oct 2024to 13 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
China12 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Guangdong Provincial Peoples Hospital Huifu Branch
Guangzhou, Guangdong, 510120
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
The First Hospital of China Medical University Hunnan Branch
Shenyang, Liaoning, 110167
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
United States4 sites
Sidney Kimmel Comprehensive Cancer At Johns Hopkins
Baltimore, Maryland, 21287
Next Virginia
Fairfax, Virginia, 22031
Columbia University Irving Medical Center
New York, New York, 10032-3725
Washington University School of Medicine
St Louis, Missouri, 63110-1010
Australia4 sites
Cancer Research South Australia
Adelaide, South Australia, SA 5000
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, NSW 2148
St Vincents Hospital
Fitzroy, Victoria, VIC 3065
Linear Clinical Research
Nedlands, Western Australia, WA 6009
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-89894 (SYH2039) Tablets in Patients With Advanced Solid Tumors
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.
- Being tested
- BG-89894
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG-89894Drug
Also called SYH2039
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a: Dose Escalation and Safety Expansion | Experimental | Sequential cohorts of increasing dose levels of BG-89894 (SYH2039) will be evaluated as monotherapy. Receives: Drug: BG-89894 |
| Phase 1b: Dose Expansion and Optimization | Experimental | Multiple indication-specific cohorts will be evaluated for safety, tolerability, and potential dose optimization of BG-89894 (SYH2039). Receives: Drug: BG-89894 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants experiencing adverse events and serious adverse events as determined per Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0), including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria.
Measured: From first dose of the study drug to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 18 months)
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
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.
Measured: Approximately 1 month
Phase 1a: Recommended dose(s) for expansion (RDFE) of BG-89894
RDFE is defined as dose level(s) recommended for expansion that will be determined based on the MTD or MAD, taking into consideration the longterm tolerability, pharmacokinetics, pharmacodynamics, preliminary antitumor activity, and any other relevant data, as available.
Measured: Approximately 18 months
Phase 1b: Recommended Phase 2 Dose (RP2D)
R2PD is defined as the dose level recommended for phase 2 that will be determined based on safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary antitumor activity, and other relevant data.
Measured: Approximately 18 months
Phase 1b: Overall Response Rate (ORR)
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Approximately 18 months
Secondary outcomes (14)
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BG-89894
Measured: Twice in the first month
Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BG-89894
Measured: Twice in the first month
Phase 1a and 1b: Apparent terminal elimination half-life (t1/2) of BG-89894
Measured: Twice in the first month
Phase 1a and 1b: Apparent volume of distribution (Vd/F) of BG-89894
Measured: Twice in the first month
Phase 1a and 1b: Apparent total clearance (CL/F) of BG-89894
Measured: Twice in the first month
Phase 1a and 1b: Area under the concentration-time curve (AUC) for BG-89894
Measured: Twice in the first month
Phase 1b: Minimum observed plasma concentration (Cmin) of BG-89894
Measured: Approximately up to 6 months
Phase 1b: Accumulation Ratio (AR) of BG-89894
Measured: Twice in the first month
Phase 1a: Overall response rate (ORR)
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1.
Measured: Approximately 18 months
Phase 1a and 1b: Duration of response (DOR)
DOR is defined as the time from the first determination of objective response that is confirmed until the first documentation of disease progression or death, whichever comes first as assessed according to RECIST v1.1 by the investigator.
Measured: Approximately 18 months
Phase 1a and 1b: Disease Control Rate (DCR)
DCR is defined as the percentage of participants with the best overall response of confirmed CR, PR, or stable disease as assessed according to RECIST v1.1 by the investigator.
Measured: Approximately 18 months
Phase 1b: Progression free survival (PFS)
PFS is defined as the time from the date of the first dose of study drug to the date of the first documentation of disease progression assessed by the investigator using RECIST v1.1 or death, whichever occurs first.
Measured: Approximately 18 months
Phase 1b: Number of particpants with AEs and SAEs
Number of participants experiencing adverse events and serious adverse events as determined per CTCAE v5.0, including findings from physical examinations, ECGs, and laboratory assessments as needed.
Measured: From first dose of the study drug to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 24 months)
Phase 1b: Plasma Concentrations
Measured: Approximately up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start12 Oct 2024
- Primary completion13 Apr 2026
- Study completion13 Apr 2026
Why it stopped: The study was discontinued following an internal decision by the sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic MTAP-deleted Solid TumorsStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568614
- Sponsor's protocol ID
- BG-89894-101
- Other IDs
- SYH2039-001, CTR20242626
- Status last verified
- May 2026
- First submitted
- 21 Aug 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-89894 (SYH2039) Tablets in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06568614
- Acronym / sponsor ID
- BG-89894-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was discontinued following an internal decision by the sponsor
- Enrolment
- 29 participants (actual)
- Lead sponsor
- BeOne MedicinesIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2024 (actual)
- Primary completion
- 13 Apr 2026 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1a: Dose Escalation and Safety Expansion | Experimental | Drug: BG-89894Sequential cohorts of increasing dose levels of BG-89894 (SYH2039) will be evaluated as monotherapy. |
| Phase 1b: Dose Expansion and Optimization | Experimental | Drug: BG-89894Multiple indication-specific cohorts will be evaluated for safety, tolerability, and potential dose optimization of BG-89894 (SYH2039). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BG-89894Also: SYH2039Administered orally | Drug | Phase 1a: Dose Escalation and Safety Expansion, Phase 1b: Dose Expansion and Optimization |
Primary outcome
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From first dose of the study drug to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 18 months)
Number of participants experiencing adverse events and serious adverse events as determined per Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0), including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria.
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
Time frame: Approximately 1 month
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.
Phase 1a: Recommended dose(s) for expansion (RDFE) of BG-89894
Time frame: Approximately 18 months
RDFE is defined as dose level(s) recommended for expansion that will be determined based on the MTD or MAD, taking into consideration the longterm tolerability, pharmacokinetics, pharmacodynamics, preliminary antitumor activity, and any other relevant data, as available.
Phase 1b: Recommended Phase 2 Dose (RP2D)
Time frame: Approximately 18 months
R2PD is defined as the dose level recommended for phase 2 that will be determined based on safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary antitumor activity, and other relevant data.
Phase 1b: Overall Response Rate (ORR)
Time frame: Approximately 18 months
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
14 secondary outcomes
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BG-89894
Time frame: Twice in the first month
Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BG-89894
Time frame: Twice in the first month
Phase 1a and 1b: Apparent terminal elimination half-life (t1/2) of BG-89894
Time frame: Twice in the first month
Phase 1a and 1b: Apparent volume of distribution (Vd/F) of BG-89894
Time frame: Twice in the first month
Phase 1a and 1b: Apparent total clearance (CL/F) of BG-89894
Time frame: Twice in the first month
Phase 1a and 1b: Area under the concentration-time curve (AUC) for BG-89894
Time frame: Twice in the first month
Phase 1b: Minimum observed plasma concentration (Cmin) of BG-89894
Time frame: Approximately up to 6 months
Phase 1b: Accumulation Ratio (AR) of BG-89894
Time frame: Twice in the first month
Phase 1a: Overall response rate (ORR)
Time frame: Approximately 18 months
Phase 1a and 1b: Duration of response (DOR)
Time frame: Approximately 18 months
Phase 1a and 1b: Disease Control Rate (DCR)
Time frame: Approximately 18 months
Phase 1b: Progression free survival (PFS)
Time frame: Approximately 18 months
Phase 1b: Number of particpants with AEs and SAEs
Time frame: From first dose of the study drug to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 24 months)
Phase 1b: Plasma Concentrations
Time frame: Approximately up to 6 months
Results and safety
The study was stopped early (reason given: The study was discontinued following an internal decision by the sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
BeOne Medicines
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BG-89894 in people with Advanced or Metastatic MTAP-deleted Solid Tumors, run by BeOne Medicines at 20 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was discontinued following an internal decision by the sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From first dose of the study drug to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 18 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.