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

Sponsor
BeiGene
Study ID
NCT05294731
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • B-cell Malignancy
  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  • DLBCL Unclassifiable
  • Follicular Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Non-Hodgkin Lymphoma
  • Richter's Transformation
  • Waldenström Macroglobulinemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BGB-16673 — DRUG
    Orally administered

Study Details

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

Key Dates

First listed
Mar 24, 2022
Start date
May 6, 2022
Status verified
Apr 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
146 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a Monotherapy Dose Escalation
    BGB-16673 will be orally administered.
  • Experimental: Phase 1b Monotherapy Safety Expansion
    BGB-16673 will be orally administered.
  • Experimental: Phase 2 Monotherapy Dose Expansion
    BGB-16673 will be administered at the recommended Phase 2 dose (RP2D) that was identified in Part 1.

Primary Outcome Measure

Phase 1: Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: From first dose of the study drug(s) to 30 days after the last dose or before initiation of a new anticancer therapy, whichever occurs first (up to approximately 3 years) ]

Central Contacts

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