NCT06589596

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

A Phase 1a/b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of PRMT5 Inhibitor BGB-58067 Alone and in Combination With Anticancer Agents in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 244 (estimated)
• Sponsor: BeOne Medicines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

BGB-58067 is a new drug designed to target a specific protein called protein arginine methyltransferase 5 (PRMT5). This protein is involved in many cell activities and can promote cancer growth when it is overactive. High levels of PRMT5 are linked to poor outcomes in several types of cancer. This new study will check how safe and helpful a potential anticancer drug called BGB-58067 is. This drug will be tested alone, in combination with BG-89894, and in combination with standard of care therapy in participants with advanced solid tumors and with MTAP deficiency. 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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	BGB-58067	Planned doses administered on specified days per protocol.
DRUG	BG-89894	Planned doses administered on specified days per protocol.
DRUG	Standard of Care Therapy	Administered in accordance with relevant local guidelines and/or prescribing information.

Timeline

• Start date: 2024-10-11
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2024-09-19
• Last updated: 2026-03-19

Locations

62 sites across 7 countries: United States, Australia, China, Denmark, France, South Korea, Spain

Regulatory

• FDA-regulated drug study