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3d
Novel BTK inhibitors and degraders for relapsed/refractory CLL/SLL: latest updates from ASH 2025 annual meeting. (PubMed, J Hematol Oncol)
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.
Journal • IO biomarker
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LYN (LYN Proto-Oncogene Src Family Tyrosine Kinase)
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bexobrutideg (NX-5948) • catadegbrutinib (BGB-16673) • docirbrutinib (AS-1763) • rocbrutinib (LP-168)
14d
New P1/2 trial
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lacutoclax (LP-108) • rocbrutinib (LP-168)
1m
New P1 trial
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gemcitabine • Rituxan (rituximab) • oxaliplatin • rocbrutinib (LP-168)
1m
ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL (clinicaltrials.gov)
P3, N=306, Recruiting, Newave Pharmaceutical Inc | Not yet recruiting --> Recruiting
Enrollment open
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TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2)
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TP53 mutation
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Jaypirca (pirtobrutinib) • rocbrutinib (LP-168)
3ms
A Study Evaluating the Effects of Itraconazole or Rifampin on the Pharmacokinetic Characteristics of Rocbrutinib Tablet (clinicaltrials.gov)
P1, N=28, Recruiting, Guangzhou Lupeng Pharmaceutical Company LTD. | Not yet recruiting --> Recruiting
Enrollment open
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itraconazole • rifampicin • rocbrutinib (LP-168)
4ms
LP-168-US-I01: Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies. (clinicaltrials.gov)
P1, N=60, Recruiting, Newave Pharmaceutical Inc | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Jul 2025 --> Dec 2027
Trial completion date • Trial primary completion date
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rocbrutinib (LP-168)
4ms
New P3 trial
|
Imbruvica (ibrutinib) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib) • Inokai (orelabrutinib) • rocbrutinib (LP-168)
4ms
New P1 trial
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itraconazole • rifampicin • rocbrutinib (LP-168)
5ms
LP-168-CN201: A Study of Rocbrutinib in Participants With Relapse or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
P2, N=62, Active, not recruiting, Guangzhou Lupeng Pharmaceutical Company LTD. | Trial completion date: Dec 2025 --> Jun 2026
Trial completion date
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rocbrutinib (LP-168)
5ms
New P3 trial
|
TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2)
|
TP53 mutation
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Jaypirca (pirtobrutinib) • rocbrutinib (LP-168)
6ms
A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma (clinicaltrials.gov)
P2, N=150, Recruiting, Guangzhou Lupeng Pharmaceutical Company LTD. | Not yet recruiting --> Recruiting
Enrollment open
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Rituxan (rituximab) • lenalidomide • bendamustine • rocbrutinib (LP-168)
9ms
New P2 trial
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Rituxan (rituximab) • lenalidomide • bendamustine • rocbrutinib (LP-168)