NCT06589596 · BeOne Medicines
An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors
What this study is about
This is an where both patients and doctors know the treatment given, conducted at multiple hospitals, first-in-human gradually increasing doses and dose expansion study to evaluate the safety, tolerability, how the drug moves through the body, how the drug affects the body, and preliminary antitumor activity of BGB-58067 alone, in combination with BG-89894 (discontinued), and in combination with the usual treatment therapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.
View original scientific description
This is an open-label, multicenter, first-in-human dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-58067 alone, in combination with BG-89894 (discontinued), and in combination with standard of care therapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants must sign the ICF and be capable of giving written informed consent
- 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; participants with advanced, metastatic, or unresectable solid tumors who have not received prior systemic treatment or have received one cycle of standard-of-care therapies will be enrolled in selected cohorts
- Adequate organ function
Exclusion criteria
- Prior treatment with any methylthioadenosine (MTA)-cooperative PRMT5 inhibitor or methionine adenosyltransferase 2a (MAT2A) inhibitor
- 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) Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Where
- Los Angeles, California
- Celebration, Florida
- Boston, Massachusetts
- St Louis, Missouri
- New York, New York
- Philadelphia, Pennsylvania
- Nashville, Tennessee
- Houston, Texas
- Irving, Texas
- Fairfax, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations