BGB-16673

DRUG12 trials

Sponsors

BeOne Medicines AG, BeOne Medicines, BeiGene, M.D. Anderson Cancer Center

Conditions

B-cell LymphomaB-cell MalignancyCLLChronic Lymphocytic LeukemiaChronic Lymphocytic Leukemia (CLL)Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaChronic Spontaneous UrticariaChronic lymphocytic leukemia (CLL)

Phase 1

A Dose-Escalation and Expansion Study of 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: 614Updated: 2026-03-18

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

RecruitingNCT05294731

BeiGeneB-cell Malignancy, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, DLBCL Unclassifiable +6

Start: 2022-05-06End: 2027-09-30Target: 146Updated: 2025-04-20

A Study to Investigate Safety and Effectiveness of 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: 2026-03-18

Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants

CompletedNCT06906809

BeiGeneHealthy Volunteers

Start: 2025-04-03End: 2025-10-13Updated: 2025-11-21

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of BGB-16673 in Adults With Chronic Spontaneous Urticaria

Active, not recruitingNCT07005713

BeiGeneChronic Spontaneous Urticaria

Start: 2025-07-19End: 2026-04-17Updated: 2026-02-03

A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies

RecruitingCTIS2024-516234-35-00

BeOne Medicines AGRelapsed or Refractory B-Cell Malignancies

Start: 2025-10-15Target: 99Updated: 2026-01-14

Phase 2

A Phase 2 Trial Of The Bruton Tyrosine Kinase Degrader BGB-16673 In Combination With BCL-2 Inhibitor Sonrotoclax For Patients With Treatment-Naive Chronic Lymphocytic Leukemia (CLL)

Not yet recruitingNCT07508995

M.D. Anderson Cancer CenterChronic Lymphocytic Leukemia (CLL)

Start: 2026-09-01End: 2033-07-01Target: 40Updated: 2026-04-03

Phase 3

A Study of 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: 2026-03-19

A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors

RecruitingNCT06970743

BeOne MedicinesChronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Start: 2025-05-29End: 2029-11-30Target: 150Updated: 2026-01-07

A Study to Evaluate the Safety and Efficacy of 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: 2026-03-18

A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator’s Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors

RecruitingCTIS2024-518893-15-00

BeOne Medicines AGChronic lymphotic leukemia and Small Lymphocytic lymphoma

Start: 2025-07-29Target: 56Updated: 2026-01-14

A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

RecruitingCTIS2025-522860-34-00

BeOne Medicines AGChronic lymphocytic leukemia (CLL), Small lymphocytic lymphoma (SLL)

Start: 2025-12-16Target: 196Updated: 2026-01-21

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