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Tacabrutideg

DRUG6 trials

Sponsors

BeOne Medicines, Massachusetts General Hospital

Conditions

B-cell LymphomaB-cell MalignancyCLLChronic Lymphocytic LeukemiaChronic Spontaneous UrticariaDiffuse Large B Cell LymphomaFollicular LymphomaMantle Cell Lymphoma

Phase 1

A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies
RecruitingNCT05006716
BeOne MedicinesB-cell Malignancy, Chronic Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma +6
Start: 2021-09-13End: 2029-11-01Target: 645Updated: 2026-09-11
A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies
RecruitingNCT06634589
BeOne MedicinesB-cell Lymphoma, B-cell Malignancy, Refractory Cancer +1
Start: 2024-11-27End: 2029-12-02Target: 80Updated: 2026-09-11
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of Tacabrutideg (BGB-16673) in Adults With Chronic Spontaneous Urticaria and in Healthy Participants
RecruitingNCT07005713
BeOne MedicinesChronic Spontaneous Urticaria
Start: 2025-07-19End: 2026-11-30Target: 58Updated: 2026-09-09

Phase 2

Zanubrutinib, Obinutuzumab, Sonrotoclax (BOSon) or BGB-16673, Obinutuzumab, Sonrotoclax (DOSon) in TN CLL/SLL
RecruitingNCT06849713
Massachusetts General HospitalChronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma (SLL)
Start: 2025-05-16End: 2030-03-01Target: 80Updated: 2026-08-11

Phase 3

A Study of Tacabrutideg (BGB-16673) Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors
RecruitingNCT06846671
BeOne MedicinesChronic Lymphocytic Leukemia, CLL
Start: 2025-04-10End: 2030-02-14Target: 250Updated: 2026-09-14
A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
RecruitingNCT06973187
BeOne MedicinesChronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Start: 2025-09-04End: 2028-04-17Target: 500Updated: 2026-09-11

Related Papers

Updated efficacy and safety results of the Bruton tyrosine kinase (BTK) degrader BGB-16673 in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) from the ongoing phase 1 CaDAnCe-101 study
Blood2025-11-031 citations
CaDAnCe-104, an ongoing, open-label, phase 1b/2 master protocol study of Bruton tyrosine kinase degrader BGB-16673 in combination with other agents in patients with relapsed/refractory B-cell malignancies
Blood2025-11-03
CaDAnCe-304, a phase 3, open-label, randomized study to evaluate the safety and efficacy of Bruton tyrosine kinase degrader BGB-16673 compared with pirtobrutinib in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma
Blood2025-11-03
Updated efficacy and safety results of the Bruton tyrosine kinase degrader BGB-16673 in patients with relapsed/refractory indolent non-Hodgkin lymphoma from the ongoing phase 1 CaDAnCe-101 study
Blood2025-11-03
Updated efficacy and safety results of the Bruton tyrosine kinase degrader BGB-16673 in patients with relapsed/refractory Waldenström macroglobulinemia from the ongoing phase 1 CaDAnCe-101 study
Blood2025-11-03
Preliminary efficacy and safety of the Bruton tyrosine kinase degrader BGB-16673 in patients with relapsed/refractory Richter transformation: Results from the ongoing phase 1 CaDAnCe-101 study
Blood2025-11-03
CaDAnCe-302, a phase 3, open-label, randomized study of BGB-16673 compared with idelalisib + rituximab (R), bendamustine + R, or venetoclax + R re-treatment in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma previously exposed to both a BTK and BCL2 inhibitor
Blood2025-11-03
Preliminary Efficacy and Safety of the Bruton Tyrosine Kinase Degrader BGB-16673 in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Results from the Phase 1 CaDAnCe-101 Study
Blood2024-11-0525 citations
Preliminary Efficacy and Safety of the Bruton Tyrosine Kinase Degrader BGB-16673 in Patients with Relapsed or Refractory Waldenström Macroglobulinemia: Results from the Phase 1 CaDAnCe-101 Study
Blood2024-11-0514 citations
Preliminary Efficacy and Safety of the Bruton Tyrosine Kinase Degrader BGB-16673 in Patients with Relapsed or Refractory (R/R) Indolent NHL: Results from the Phase 1 CaDAnCe-101 Study
Blood2024-11-053 citations
Bgb-16673, a Selective BTK Degrader, Exhibits Deeper Inhibition of Cancer Cell Signaling Pathways and Better Efficacy in MCL Models
Blood2024-11-05
First Results from a Phase 1, First-in-Human Study of the Bruton's Tyrosine Kinase (BTK) Degrader Bgb-16673 in Patients (Pts) with Relapsed or Refractory (R/R) B-Cell Malignancies (BGB-16673-101)
Blood2023-11-0258 citations
P1219: BGB-16673, A BTK DEGRADER, OVERCOMES ON-TARGET RESISTANCE FROM BTK INHIBITORS AND PRESENTS SUSTAINABLE LONG-TERM TUMOR REGRESSION IN LYMPHOMA XENOGRAFT MODELS
HemaSphere2023-08-019 citations
P1239: BRUTON TYROSINE KINASE (BTK) PROTEIN DEGRADER BGB-16673 IS LESS APT TO CAUSE, AND ABLE TO OVERCOME VARIABLE BTK RESISTANCE MUTATIONS COMPARED TO OTHER BTK INHIBITORS (BTKI)
HemaSphere2023-08-017 citations
P686: A PHASE 1 FIRST IN-HUMAN STUDY OF BGB-16673, A BRUTON TYROSINE KINASE PROTEIN DEGRADER, IN PATIENTS (PTS) WITH B-CELL MALIGNANCIES (TRIAL IN PROGRESS)
HemaSphere2022-06-015 citations