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OncoMatch/Clinical Trials/NCT05006716

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

Is NCT05006716 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies BGB-16673 for b-cell malignancy.

Phase 1/2RecruitingBeOne MedicinesNCT05006716Data as of Sep 2026Location: International · 16 countries

Treatment: BGB-16673Study 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)

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Extracted eligibility criteria

Treatments studied

Other

BGB-16673

Cancer type

Non-Hodgkin Lymphoma

Chronic Lymphocytic Leukemia

Diffuse Large B-Cell Lymphoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: Bruton tyrosine kinase inhibitor — any line of therapy

Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance)

Must have received: Bruton tyrosine kinase inhibitor — any line of therapy

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

Must have received: Bruton tyrosine kinase inhibitor — Phase 2 Cohorts in R/R CLL/SLL, R/R MCL, and R/R WM

Participants who previously received a BTKi are eligible if they had disease progression on only one regimen containing a covalent BTKi. Note: Participants may have received treatment with ≥ 2 different covalent BTKis if additional BTKis were discontinued secondary to an event other than disease progression.

Must have received: Bruton tyrosine kinase inhibitor — MCL expansion cohorts (Phase 2)

participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy

Must have received: Bruton tyrosine kinase inhibitor — CLL/SLL expansion cohorts (Phase 2)

CLL/SLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2)

Must have received: Bcl-2 inhibitor — CLL/SLL expansion cohorts (Phase 2)

CLL/SLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Alabama At Birmingham Hospital · Birmingham, Alabama
  • Mayo Clinic Phoenix · Phoenix, Arizona
  • Honor Health Research Institute · Scottsdale, Arizona
  • University of Arizona Cancer Center · Tucson, Arizona
  • University of California San Diego (Ucsd) Moores Cancer Center · La Jolla, California

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT05006716 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received Bruton tyrosine kinase inhibitor and Bruton tyrosine kinase inhibitor.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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