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

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor

In brief

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 (discontinued), and in combination with standard of care therapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.

Key facts

Study ID

NCT06589596

Run by

BeOne Medicines

People needed

525

Starts

2025-01-10

Expected to finish

2027-09-30

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Adventhealth — Celebration, Florida, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Nyu Langone Health — New York, New York, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
• Tennessee Oncology, Pllc Nashville — Nashville, Tennessee, United States (enrolling)
• The University of Texas Md Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Next Dallas — Irving, Texas, United States (enrolling)
• Next Virginia — Fairfax, Virginia, United States (enrolling)
• Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia (enrolling)
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (enrolling)
• Monash Health — Clayton, Victoria, Australia (enrolling)
• Austin Health — Heidelberg, Victoria, Australia (enrolling)
• Linear Clinical Research — Nedlands, Western Australia, Australia (enrolling)
• Fundacao Pio Xii Hospital de Amor de Barretos — Barretos, Brazil (enrolling)
• Fundacao Universidade de Caxias Do Sul — Caxias do Sul, Brazil (enrolling)
• Centro Gaucho Integrado de Oncologia Hospital Mae de Deus — Porto Alegre, Brazil (enrolling)
• Hospital Sao Lucas Da Pucrs — Porto Alegre, Brazil (enrolling)
• Ensino E Terapia de Inovacao Clinica Amo Etica — Salvador, Brazil (enrolling)
• Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira — São Paulo, Brazil (enrolling)
• Nucleo de Pesquisa E Ensino Da Rede Sao Camilo — São Paulo, Brazil (enrolling)
• Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein — São Paulo, Brazil (enrolling)
• The Second Hospital of Anhui Medical University — Hefei, Anhui, China (enrolling)
• Usc Norris Comprehensive Cancer Center (Nccc) — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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