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An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors
Trial Status: active
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, and in
combination with standard of care therapy in participants with advanced solid tumors and
with methylthioadenosine phosphorylase (MTAP) deficiency.
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06589596.
