Phase 1 Study of BGB-58067 Alone and With Other Cancer Treatments for Advanced Solid Tumors with MTAP Deficiency

What this Trial Is About

Researchers are evaluating BGB-58067, a new drug targeting the protein PRMT5, which can promote cancer growth when overactive. This open-label, first-in-human study focuses on participants with advanced solid tumors that have a deficiency in methylthioadenosine phosphorylase MTAP. The study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early antitumor activity of BGB-58067 alone and in combination with other therapies. Participants will receive BGB-58067 alone or combined with standard care therapies, with dosing increasing in sequential groups to find safe and effective dose levels. Although combination with BG-89894 was initially studied, its enrollment has been discontinued. The study includes dose escalation phases and expansion phases to optimize dosing based on emerging data. Participants will be closely monitored for side effects and response to treatment from the first dose through follow-up periods lasting up to approximately two years. Assessments include clinical evaluations, laboratory tests, and measures of tumor response. The primary outcomes focus on adverse events, dose tolerability, and tumor response rates to understand the drugs safety profile and preliminary effectiveness.

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