Last updated 5 days ago
An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors
695 patients around the world
Available in United States, Brazil, Spain
A solid tumor is an abnormal lump or mass of tissue that forms when cells grow out of control. Solid tumors can develop in organs, bones, or soft tissues. An advanced or metastatic solid tumor is a cancer that has either grown into nearby tissues (advanced) or spread to distant parts of the body (metastatic).
BGB-58067 works by blocking a protein in the body called PRMT5. Although all cells need PRMT5 to function normally, cancer cells depend on it more heavily for growth and survival. In some cancers (about 15% of all cancers), a gene called MTAP is deficient, leading to the buildup of a substance called methylthioadenosine (MTA). This buildup makes the cancer cells more sensitive to blocking PRMT5. The aim of this approach is to selectively target cancer cells with MTAP deficiency, reduce harm to healthy tissues, and reduce side effects.
The purpose of this study is to test how safe and helpful BGB-58067 is when given alone, in combination with standard of care therapy, and in combination with novel anticancer therapies in participants with advanced solid tumors and with MTAP deficiency. The main goals of this study are to ensure the treatments are safe by monitoring side effects and to understand how well patients respond to the treatment and whether their cancers shrink or disappear.
This study consists of dose escalation and dose expansion parts. During the dose escalation part, the study doctors will test different doses of the study drug(s) to find the recommended dose that people can take without having serious side effects. During the dose expansion part, the study doctors will test the study drug(s) in a larger number of people using the dose(s) identified from dose escalation.
The overall time to participate in this study is up to approximately 2 years. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor and imaging tests.
Note: Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
BeOne Medicines
3Research sites
695Patients around the world
This study is for people with
Solid tumors
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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).
Sites
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Mãe de Deus Hospital
Recruiting
Clínica AMO
Recruiting
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
Recruiting
SponsorBeOne Medicines
Study typeInterventional
Conditions
Solid tumors
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06589596
