Clinical Trials

Date: 2017-03-02

Type of information: Treatment of the first patient

phase: 2

Announcement: treatment of the first patient

Company: BeiGene (China)

Product: BGB-3111

Action mechanism:

• kinase inhibitor/Bruton tyrosine kinase inhibitor. BGB-3111 is an investigational, oral, highly selective and potent inhibitor of Bruton tyrosine kinase (BTK). Bruton tyrosine kinase (BTK), a member of the TEC family of kinases, is a signaling molecule positioned within the B-cell receptor signaling cascade. BTK is predominantly expressed in B lymphocytes at various stages of development. Activation of BTK in B cells initiates a series of signaling events that leads to the expression of genes involved in proliferation and survival. Several BTK inhibitors have demonstrated sustained antitumor responses as a single agent in patients with B-cell malignancies

Disease: relapsed or refractory mantle cell lymphoma

Therapeutic area: Cancer - Oncology

Country: China

Trial details:

• The Phase II single-arm, open-label, multi-center study is designed to investigate the efficacy and safety of BGB-3111 in patients with relapsed or refractory MCL.
• The study’s primary endpoint is the objective response rate, defined as achievement of either a partial response or complete response at any time on study drug. Secondary endpoints include progression free survival, duration of response, time to response, safety, and tolerability. Professor Jun Zhu of the Beijing Cancer Hospital is the lead principal investigator of the trial. (NCT03145064)

Latest news:

• • On March 2, 2017, BeiGene announced the dosing of the first patient in a pivotal clinical trial of BGB-3111, an investigational Bruton’s Tyrosine Kinase (BTK) inhibitor, in Chinese patients with relapsed or refractory mantle cell lymphoma. This study is Beigene's first pivotal trial in China with one of its portfolio compounds.
• BGB-3111 is also currently being evaluated in a global Phase III study in comparison with ibrutinib for the treatment of patients with Waldenström’s Macroglobulinemia.

 

Is general: Yes