BeiGene, a clinical-stage biopharmaceutical company focused on developing molecularly-targeted and immuno-oncology drugs for the treatment of cancer, announced that the first patient has been dosed with BGB-283 in a Phase I clinical trial in China, a novel RAF dimer inhibitor for the treatment of solid tumors harboring B-RAF mutations and other aberrations in the RAS-MAPK (mitogen-activated protein kinase) pathway. The study is being conducted across multiple centers in China.
"We are extremely excited about the initiation of the BGB-283 study in China. This is another important milestone for BeiGene" said John V. Oyler, CEO. "BGB-283 represents one of the BeiGene compounds supported by China's 12-5 Major New Drugs Development Projects. We hope that this novel targeted anti-cancer agent will bring benefits to cancer patients in China."
"Ongoing clinical trials of BGB-283 in Australia and New Zealand have shown promising early anti-tumor activities as well as a favorable safety profile," Jason Yang, MD, PhD, senior vice president, head of clinical development commented. "We will explore the safety and tolerability, and the antitumor activity of BGB-283 in cancer patients in China."
The clinical trial in China will investigate BGB-283 in patients with B-RAF mutations in a range of tumors for which no other effective standard therapies are currently available in China. Additionally, BGB-283 will be investigated in patients with K-RAS/N-RAS mutated cancers and hepatocellular carcinoma (HCC).
The phase I multi-center, open-label, dose escalation clinical trial of BGB-283 is designed to assess the safety, tolerability and pharmacokinetic properties of BGB-283 as a single agent. Key objectives in the study include determining the maximum tolerated dose, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BGB-283 in Chinese patients. Disease-specific expansion cohorts will be dosed to investigate the preliminary anti-tumor activity of BGB-283 in selected solid tumors.
