Open Actively Recruiting

A Phase 1 Dose-Escalation and Expansion Study of BGB-16673 in Patients With B-Cell Malignancies

About

Brief Summary

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

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria :

  • Provision of signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection
  • Age ≥ 18 years
  • Confirmed diagnosis (per World Health Organization [WHO] guidelines, unless otherwise noted) of one of the following: MZL (Part 1a and 1b only), FL (Part 1a only), MCL, CLL/SLL, WM (Part 1a and 1b only), DLBCL (Part 1a only), or >2 treatments per the Richter's transformation to DLBCL (Part 1a only).
  • Patients who have previously received a covalently-binding BTK inhibitor in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).
  • For dose-finding and dose-expansion, patients who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.
  • Measurable disease by radiographic assessment or serum IgM level (WM only)
  • ECOG Performance Status of 0 to 2
  • Patients enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; patients with CLL/SLL or MCL enrolling in the expansion cohorts (Part 2) must have been treated with a BTKi in a prior line of therapy.

Exclusion Criteria:

  • 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
  • Requires ongoing systemic treatment for any other malignancy
  • Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment.
  • 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 patient had received treatment for central nervous system disease
  • 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, 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 Richter's transformation of an indolent lymphoma to an aggressive histology (only patients with Richter Transformation to DLBCL are eligible for Part 1a).

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

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
22-000757
Category
Hematology-Oncology
Oncology
Contact
Shenetra Walker
For Providers
NCT No.
NCT05006716
For detailed technical eligibility, visit ClinicalTrials.gov.