Testing BGB-58067 for advanced solid tumors with MTAP deficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants must sign the Informed Consent Form 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; documented RAS mutation status or KRAS mutation is required for selected cohorts
* 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 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 human immunodeficiency virus (HIV) infection. Participants with treated HIV infection may be included in Phase 1b if they meet certain criteria
* High cardiovascular risk factors
* QT interval corrected by Fridericia's method (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 it's running

• Cancer and Blood Specialty Clinic
  Los Alamitos, California, United States Recruiting
• Usc Norris Comprehensive Cancer Center (Nccc)
  Los Angeles, California, United States Recruiting
• Adventhealth
  Celebration, Florida, United States Recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting
• Nyu Langone Health
  New York, New York, United States Recruiting

+51 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 1.877.828.5568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.