^
    6d
    DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (TAI-SHAN9) (clinicaltrials.gov)
    P2, N=59, Active, not recruiting, Dizal Pharmaceuticals | Recruiting --> Active, not recruiting | N=180 --> 59 | Trial completion date: Apr 2028 --> Aug 2026 | Trial primary completion date: Oct 2027 --> Jan 2026
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    birelentinib (DZD8586)
    1m
    A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6) (clinicaltrials.gov)
    P3, N=250, Recruiting, Dizal (Jiangsu) Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Rituxan (rituximab) • Zydelig (idelalisib) • bendamustine • birelentinib (DZD8586)
    1m
    A Study of DZD8586 Combination in CLL/SLL (TAI-SHAN10) (clinicaltrials.gov)
    P2, N=66, Recruiting, Dizal (Jiangsu) Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Venclexta (venetoclax) • birelentinib (DZD8586)
    4ms
    A Study of DZD8586 Combination in CLL/SLL (TAI-SHAN10) (clinicaltrials.gov)
    P2, N=66, Not yet recruiting, Dizal (Jiangsu) Pharmaceutical Co., Ltd.
    New P2 trial
    |
    Venclexta (venetoclax) • birelentinib (DZD8586)
    4ms
    DZD8586 Combination Therapy in Patients With Diffuse Large B-cell Lymphoma (TAI-SHAN12) (clinicaltrials.gov)
    P1/2, N=150, Recruiting, Dizal Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • oxaliplatin • birelentinib (DZD8586)
    4ms
    A Phase 3 Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6) (clinicaltrials.gov)
    P3, N=250, Not yet recruiting, Dizal (Jiangsu) Pharmaceutical Co., Ltd.
    New P3 trial
    |
    Rituxan (rituximab) • Zydelig (idelalisib) • bendamustine • birelentinib (DZD8586)
    5ms
    DZD8586 Combination Therapy in Patients With Diffuse Large B-cell Lymphoma (TAI-SHAN12) (clinicaltrials.gov)
    P1/2, N=150, Not yet recruiting, Dizal Pharmaceuticals
    New P1/2 trial
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • oxaliplatin • birelentinib (DZD8586)
    10ms
    A Study of DZD8586 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (TAI-SHAN1) (clinicaltrials.gov)
    P1/2, N=17, Completed, Dizal Pharmaceuticals | Recruiting --> Completed | N=386 --> 17 | Trial completion date: Oct 2027 --> Feb 2024 | Trial primary completion date: Apr 2027 --> Feb 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    birelentinib (DZD8586)
    over1year
    DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (TAI-SHAN9) (clinicaltrials.gov)
    P2, N=180, Recruiting, Dizal Pharmaceuticals
    New P2 trial
    |
    birelentinib (DZD8586)
    over1year
    DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8) (clinicaltrials.gov)
    P2, N=155, Recruiting, Dizal Pharmaceuticals
    New P2 trial
    |
    birelentinib (DZD8586)
    over1year
    TAI-SHAN5: DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=230, Recruiting, Dizal Pharmaceuticals | Not yet recruiting --> Recruiting | N=20 --> 230
    Enrollment open • Enrollment change
    |
    birelentinib (DZD8586)
    2years
    First Report of Phase 1 Studies of DZD8586, a BBB Penetrant LYN/BTK Dual Inhibitor, in Patients with B-Cell Non-Hodgkin Lymphoma (B-NHL) (ASH 2023)
    Introduction Resistance to covalent (ibrutinib, acalabrutinib and zanubrutinib) and non-covalent BTK inhibitors (pirtobrutinib) is an emerging clinical challenge...Methods TAI-SHAN1 (NCT05844956; CTR20220558) and TAI-SHAN5 (NCT05824585) are phase 1 dose escalation and expansion studies in patients with r/r B-NHL...The combination of BBB penetration, dual inhibition of LYN/BTK and potential to overcome C481S mutant CLL and other covalent BTKi resistant lymphomas suggest this may be a useful agent. Updated data will be presented at the meeting.
    Clinical • P1 data
    |
    LYN (LYN Proto-Oncogene Src Family Tyrosine Kinase)
    |
    Imbruvica (ibrutinib) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib) • Jaypirca (pirtobrutinib) • birelentinib (DZD8586)