Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeiGene

About this trial

This study aims to explore the recommended phase 2 dose and evaluate the safety, tolerability and preliminary antitumor activity of BGB-16673 monotherapy at the recommended Phase 2 dose for the selected B-cell malignancy expansion cohorts

Eligibility criteria

Qualifiers

Provision of signed and dated written informed consent prior to any study

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2

Adequate organ function of coagulation function, liver function, renal function and pancreatic function and measure disease per disease-specific response criteria

Phase 1: Confirmed diagnosis of R/R Marginal Zone Lymphoma (MZL), Follicular Lymphoma (grade 1-3a), Waldenström Macroglobulinemia (WM), non-germinal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL), Richter's transformation to DLBCL, MCL, or CLL/SLL

Disqualifiers

Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer

Require ongoing systemic treatment for any other malignancy or systemic corticosteroid treatment

Receiving treatment with a strong CYP3A inhibitor or inducer ≤ 14 days before the first dose of BGB-16673, or proton-pump inhibitors ≤ 5 days before the first dose of BGB-16673.

Current or history of central nervous involvement

Trial design

Treatments tested in this trial

  • BGB-16673

Treatment groups

146 Participants
are divided into 3 treatment groups

Sponsors and collaborators