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Testing BGB-58067 for advanced solid tumors with MTAP deficiency

A Phase 1a/b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of PRMT5 Inhibitor BGB-58067 Alone and in Combination With Anticancer Agents in Patients With Advanced Solid Tumors

Phase 1 Interventional BeOne Medicines · NCT06589596

This study is testing a new drug called BGB-58067 to see if it can help people with advanced solid tumors that have a specific genetic deficiency when other treatments haven't worked.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment525 (estimated)
Ages18 Years and up
SexAll
SponsorBeOne Medicines Industry-sponsored
Locations80 sites (Los Angeles, California and 79 other locations)
Trial IDNCT06589596 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter study evaluates the safety and effectiveness of BGB-58067, a new drug targeting the PRMT5 protein, in patients with advanced solid tumors and MTAP deficiency. The study involves a dose escalation and expansion phase to assess pharmacokinetics, pharmacodynamics, and preliminary antitumor activity. Participants will receive BGB-58067 as a monotherapy after having previously undergone standard systemic therapy or when no other treatment options are available. The study aims to provide insights into the drug's potential as a treatment for this specific patient population.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced, metastatic, or unresectable solid tumors who have a confirmed MTAP deficiency.

Not a fit: Patients with prior treatment using PRMT5 inhibitors or those with active leptomeningeal disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors that have limited treatment alternatives.

How similar studies have performed: While this approach is novel in targeting PRMT5 specifically, similar studies targeting other pathways have shown promise in treating advanced solid tumors.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Los Angeles, California and 79 other locations

+30 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid Tumoradvanced solid tumorBGB-58067MTAP deficiency
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.