Phase 1 studies of docirbrutinib and rocbrutinib demonstrated target engagement across wild-type and resistance-associated BTK mutations with encouraging safety profiles and preliminary efficacy signals in heavily pretreated populations...BTK degraders, including bexobrutideg and BGB-16673, demonstrated rapid and deep responses, activity in high-risk molecular subgroups, and manageable toxicity profiles, with recommended phase 2 doses established. Collectively, these latest updates support continued clinical development of novel agents to address resistance and disease progression in R/R CLL/SLL.

3 days ago

Journal • IO biomarker

LYN (LYN Proto-Oncogene Src Family Tyrosine Kinase)

bexobrutideg (NX-5948) • catadegbrutinib (BGB-16673) • docirbrutinib (AS-1763) • rocbrutinib (LP-168)

CaDAnCe-104: A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies (clinicaltrials.gov)

P1/2, N=80, Recruiting, BeOne Medicines

1 month ago

New P1/2 trial

Gazyva (obinutuzumab) • Brukinsa (zanubrutinib) • Beqalzi (sonrotoclax) • Lunsumio (mosunetuzumab-axgb) • Columvi (glofitamab-gxbm) • catadegbrutinib (BGB-16673)

2ms

BGB-16673-102: Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader (clinicaltrials.gov)

P1/2, N=146, Recruiting, BeiGene | Trial completion date: Sep 2027 --> Jan 2029 | Trial primary completion date: Feb 2026 --> Jan 2029

2 months ago

Trial completion date • Trial primary completion date

catadegbrutinib (BGB-16673)

2ms

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) (clinicaltrials.gov)

P2, N=40, Not yet recruiting, M.D. Anderson Cancer Center

2 months ago

New P2 trial

Beqalzi (sonrotoclax) • catadegbrutinib (BGB-16673)

4ms

BGB-16673-104: A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies (2024-516234-35-00)

P1/2, N=99, Recruiting, BeOne Medicines AG

4 months ago

New P1/2 trial

Gazyva (obinutuzumab) • Brukinsa (zanubrutinib) • Beqalzi (sonrotoclax) • Lunsumio (mosunetuzumab-axgb) • Columvi (glofitamab-gxbm) • catadegbrutinib (BGB-16673)

4ms

BGB-16673-304: A 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. (2025-522860-34-00)

P2/3, N=196, Recruiting, BeOne Medicines AG

4 months ago

New P2/3 trial

Jaypirca (pirtobrutinib) • catadegbrutinib (BGB-16673)

4ms

ALLG NHL43: An open-label multi-centre international phase 2 trial to evaluate the safety and efficacy of two years fixed duration therapy with sonrotoclax in combination with the BGB-16673 and rituximab in patients with treatment naïve or BTKi naïve/intolerant Waldenström Macroglobulinemia (WM). (ACTRN12626000174381)

P2, N=80, Not yet recruiting, Australasian Leukaemia and Lymphoma Group

4 months ago

New P2 trial

CXCR4 (Chemokine (C-X-C motif) receptor 4)

Rituxan (rituximab) • Beqalzi (sonrotoclax) • catadegbrutinib (BGB-16673)

4ms

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

P1, N=34, Active, not recruiting, BeiGene | Recruiting --> Active, not recruiting | Trial completion date: Sep 2026 --> Apr 2026 | Trial primary completion date: Sep 2026 --> Apr 2026

4 months ago

Enrollment closed • Trial completion date • Trial primary completion date

catadegbrutinib (BGB-16673)

7ms

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

P1, N=37, Completed, BeiGene | Recruiting --> Completed

7 months ago

Trial completion

itraconazole • catadegbrutinib (BGB-16673)

8ms

Invasive Cutaneous Mucormycosis in a Patient With Chronic Lymphocytic Leukemia on Obinutuzumab, Idelalisib, and Bruton Tyrosine Kinase Degrader: A Case Report. (PubMed, Cureus)

We present a case of invasive cutaneous mucormycosis in an elderly man with chronic lymphocytic leukemia (CLL), who was receiving a Bruton tyrosine kinase (BTK)-targeted protein degrader trial drug (BGB-16673), obinutuzumab, a newer anti-CD20 monoclonal therapy, and idelalisib, a phosphoinositide 3-kinase inhibitor. Clinical cure was achieved with limb amputation, given the extent of disease. This case underscores the necessity of a low index of suspicion for mucormycosis on presentation, critical appraisal of the patient's risk factors, and a multimodal approach to diagnosis.

8 months ago

Journal

BTK (Bruton Tyrosine Kinase)

Gazyva (obinutuzumab) • Zydelig (idelalisib) • catadegbrutinib (BGB-16673)

8ms

CaDAnCe-101: A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies (clinicaltrials.gov)

P1/2, N=614, Recruiting, BeiGene | Trial completion date: Dec 2028 --> Nov 2029 | Trial primary completion date: Dec 2025 --> Nov 2026

8 months ago

Trial completion date • Trial primary completion date

catadegbrutinib (BGB-16673)

8ms

BGB-16673-304: 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 (clinicaltrials.gov)

P3, N=500, Recruiting, BeiGene | Not yet recruiting --> Recruiting

8 months ago

Enrollment open

Jaypirca (pirtobrutinib) • catadegbrutinib (BGB-16673)