BGB-58067 / BeOne Medicines - LARVOL DELTA

An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=237 | Recruiting | Sponsor: BeiGene | N=92 ➔ 237 | Trial completion date: Nov 2026 ➔ Jun 2027 | Trial primary completion date: Nov 2026 ➔ Jun 2027

Enrollment change • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Trial in progress: A first-in-human phase 1a/b study of BGB-58067, an MTA-cooperative PRMT5 inhibitor, in patients with advanced solid tumors and MTAP deficiency (AACR 2025) - P1 | "For phase 1b, the primary objectives are to determine the recommended phase 2 dose and to assess the antitumor activity (ORR per investigator); secondary objectives are to further assess antitumor activity (DOR, DCR and progression-free survival per investigator) and safety/tolerability of BGB-58067. As of December 2024, the trial is actively recruiting patients in Australia, China, and the United States."

Clinical • Metastases • P1 data • Bladder Cancer • Brain Cancer • CNS Tumor • Genito-urinary Cancer • Glioblastoma • Oncology • Pancreatic Cancer • Solid Tumor • MTAP • PRMT5

BeiGene Announces Global Licensing Agreement for MAT2A Inhibitor (Businesswire) - "BeiGene...announced it has entered into a global licensing agreement with CSPC Zhongqi Pharmaceutical Technology...for SYH2039, a novel methionine adenosyltransferase 2A (MAT2A)-inhibitor being explored for solid tumors....'This MAT2A inhibitor is a valuable addition to our solid tumor pipeline, and we’re eager to explore its potential, particularly in combination with our internally developed PRMT5 inhibitor, BGB-58067'....BGB-58067, which is on track to enter the clinic before the end of the year, is designed to avoid on-target hematological toxicity seen with first-generation PRMT5 inhibitors....Under the terms of the agreement, BeiGene has an exclusive license to develop, manufacture and commercialize SYH2039 worldwide. CSPC will receive upfront and time-based payments totaling $150 million and will be eligible for payments upon the achievement of certain development and commercial milestones and tiered royalties."

Licensing / partnership • New trial • Solid Tumor

An Investigational Study of BGB-58067 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=92 | Recruiting | Sponsor: BeiGene | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

BeiGene's PRMT5 inhibitor BGB-58067 clinical trial application accepted, leading the way in anti-cancer treatment [Google translation] (pharnexcloud.com) - "On September 10, according to the official website of the CDE, BeiGene 's application for clinical trial of BGB-58067 tablets, a Class 1 new drug, was accepted. According to the company's public information, BGB-58067 is a PRMT5 inhibitor and a solid tumor product under development by BeiGene, which is expected to enter the clinical research stage in 2024...According to BeiGene's public information, the MTA-synergistic PRMT5 inhibitor developed by the company is highly effective and selective, and has brain penetration, and is expected to be used for solid tumors such as non-small cell lung cancer and gastrointestinal tumors."

New trial • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

An Investigational Study of BGB-58067 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=92 | Not yet recruiting | Sponsor: BeiGene

Metastases • New P1 trial • Oncology • Solid Tumor