BGB-16673-101 is a Phase 1/2, open-label, multicenter study evaluating the BTK-targeted protein degrader BGB-16673 in patients with relapsed or refractory B-cell malignancies. The primary objectives are to evaluate safety, tolerability, and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Eligible participants are adults with B-cell malignancies (e.g., CLL, SLL, MCL, MZL, FL, DLBCL, or WM) who have received at least two prior lines of therapy for aggressive lymphomas or one for indolent subtypes. The study design consists of a dose-escalation phase followed by dose-expansion cohorts. Key secondary endpoints include pharmacokinetic parameters and preliminary antitumor activity measured by objective response rate (ORR) and duration of response (DOR).
This clinical study evaluates a new investigational drug called BGB-16673 in patients with various types of lymphoid cancers known as B-cell malignancies. The primary goal is to assess the safety of the drug and to determine the most appropriate dosage for treatment. The study includes adults whose cancer has progressed despite standard treatments or who have no other remaining treatment options. In the initial phase, the dose is gradually increased to closely monitor how well patients tolerate the medication. Later, the drug's effectiveness will be studied in larger groups with specific subtypes of the disease. This research helps to understand how the body processes the drug and whether it can effectively slow down tumor growth.
