A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

Sponsor: BeiGene

Sponsor score: 40

ClinicalTrials ID:NCT05006716

This clinical trial investigates BGB-16673, an orally administered drug, in participants with B-cell malignancies. The study includes a Phase 1 dose-escalation to determine safety and optimal dosing, followed by a Phase 2 expansion to further assess efficacy. Eligibility criteria focus on individuals diagnosed with specific B-cell malignancies.

Patient Parameters

Program Overview

Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)

Eligibility Criteria

Exclusion Criteria

  1. Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.
  2. Requires ongoing systemic treatment for any other malignancy
  3. Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment.
  4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease
  5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

FACILITYZIPCITYSTATE
University of Alabama At Birmingham Hospital35294BirminghamAlabama
Western Regional Medical Center, Llc85338GoodyearArizona
Mayo Clinic Phoenix85254PhoenixArizona
Honor Health Research Institute85258ScottsdaleArizona
University of Arizona Cancer Center85724TucsonArizona
University of California San Diego (Ucsd) Moores Cancer Center92037La JollaCalifornia
UCLA Santa Monica Cancer Care90404Santa MonicaCalifornia
Stanford Medicine94305StanfordCalifornia
Uchealth North80528Fort CollinsColorado
Mayo Clinic Jacksonville32224JacksonvilleFlorida

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