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Study of BGB-58067 for Advanced Solid Tumors with MTAP Deficiency

This study is testing a new drug called BGB-58067 for people with advanced solid tumors that have a specific genetic change called MTAP deficiency. BGB-58067 is designed to target a protein called PRMT5, which can contribute to cancer growth. Researchers want to see how safe BGB-58067 is when given alone and with standard cancer treatments. To join, you must be at least 18 years old, have a good general health status, and your tumor must show evidence of MTAP loss. The main goals are to understand side effects and find the best dose of BGB-58067. The study is currently recruiting 525 participants.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll 525 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for side effects from the first dose until 30 days after your last dose or starting a new cancer treatment, which is approximately 13 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06589596

An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
BeOne Medicines
~525 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:BGB-58067BG-89894Standard of Care Therapy

At a glance

Recruiting sites
98 of 98 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a: Number of Participants with Adverse Events and Serious Adverse Events
Measured over From first dose of the study drug(s) to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 13 months)
+5 more outcomes measured

Conditions

Advanced Solid Tumor

Explore related trials

Solid NeoplasmMTAP Gene

Where it's being run

98 sites across 43 states
Brazil8
Guangdong5
Shanghai Municipality5
Zhejiang5
France5
Malaysia5
Thailand5
Beijing Municipality4

Study leadership

  • Study Director · STUDY_DIRECTOR · BeOne Medicines

Who to contact

Study Director
[email protected]
1.877.828.5568
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Phase 1a: Number of Participants with Adverse Events and Serious Adverse EventsFrom first dose of the study drug(s) to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 13 months)

    Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), and laboratory assessments.

  • Phase 1a: Number of Participants with Adverse Events that meet Dose-Limiting Toxicity (DLT) criteriaApproximately 1 month
  • Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapyApproximately 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. Note: BGB-58067 + BG-89894 combination has been discontinued.

  • Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapyApproximately 13 months

    RDFE of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy will be determined based upon the MTD or MAD. Note: BGB-58067 + BG-89894 combination has been discontinued.

  • Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-58067 alone and in combination with standard of care therapyApproximately 2 years

    RP2D established from Phase 1a for BGB-58067 alone and in combination with standard of care therapy for administration in selected tumor types.

  • Phase 1b: Objective Response Rate (ORR)Approximately 2 years

    ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR), as assessed by the investigator.