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RecruitingLast updated: 2 July 2026

This study is recruiting people with advanced solid cancers with MTAP deficiency to investigate the recommended dose level, safety and effect of a new drug (called BGB-58067)A Phase 1a/b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-58067, an MTA-Cooperative PRMT5 Inhibitor in Patients With Advanced Solid Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Clinical summary

Summary

BGB-58067 is a new drug designed to target a protein called PRMT5. This protein is involved in many cell processes and can help cancer growth when it is overactive. High levels of PRMT5 are linked to poor outcomes in several types of cancer.

This study is looking at how safe BGB-58067 is, how it behaves in the body, and whether it shows early signs of working.

The drug will be tested:

  • on its own;
  • in combination with BG-89894; and
  • in combination with standard of care therapy.

The study is recruiting people with advanced solid cancers that cannot be removed with surgery, have spread, or are locally advanced, and have a tumour with MTAP deficiency.

Most participants will have had treatment before, and their cancer has come back or worsened, or there are no suitable standard treatment options available. Some groups in the study may include people who have not yet received treatment.

Conditions

This trial is treating people with advanced, metastatic or inoperable (unresectable) solid cancers who have previously received treatment and whose tumours are MTAP deficient

Eligibility

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)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You are currently being treated on a clinical trial.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT06589596 *
  • 2024-515307-19-00 *
  • BGB-58067-101; CTR20244451

Trial sponsor

BeiGene

Scientific Title

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

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