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    DRUG CLASS:

    CD123-targeted antibody-drug conjugate

    Related drugs:
    8d
    A Study to Assess Adverse Events and How Intravenous (IV) Pivekimab Sunirine Moves Through the Body in Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
    P1, N=18, Recruiting, AbbVie | Not yet recruiting --> Recruiting | Trial completion date: Apr 2028 --> Mar 2030 | Initiation date: Jan 2026 --> May 2026
    Enrollment open • Trial completion date • Trial initiation date • Adverse events
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    Decnupaz (pivekimab sunirine-pvzy)
    29d
    REVIVAL: A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
    P2/3, N=660, Not yet recruiting, AbbVie
    New P2/3 trial • Adverse events
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    Venclexta (venetoclax) • azacitidine • Decnupaz (pivekimab sunirine-pvzy)
    1m
    Study of AZD9829 in CD123+ Hematological Malignancies (clinicaltrials.gov)
    P1/2, N=56, Active, not recruiting, AstraZeneca | Completed --> Active, not recruiting
    Enrollment closed
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    2ms
    M25-692: A Study to Assess Adverse Events and How Pivekimab Sunirine Moves Through the Body of Pediatric Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) (2024-520125-36-00)
    P1, N=18, Not yet recruiting, AbbVie Deutschland GmbH & Co. KG
    New P1 trial • Adverse events
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    Decnupaz (pivekimab sunirine-pvzy)
    2ms
    NCI-2023-03572: Combination Chemotherapy (FLAG-Ida) With Pivekimab Sunirine (PVEK [IMGN632]) for the Treatment of Newly Diagnosed Adverse Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms (clinicaltrials.gov)
    P1, N=30, Active, not recruiting, Fred Hutchinson Cancer Center | Recruiting --> Active, not recruiting | Trial completion date: Dec 2029 --> May 2029 | Trial primary completion date: Dec 2026 --> May 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    Chr t(15;17)
    |
    cytarabine • idarubicin hydrochloride • fludarabine IV • Decnupaz (pivekimab sunirine-pvzy) • Starasid (cytarabine ocfosfate)
    3ms
    Study of AZD9829 in CD123+ Hematological Malignancies (clinicaltrials.gov)
    P1/2, N=56, Completed, AstraZeneca | Active, not recruiting --> Completed
    Trial completion
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    4ms
    NCI-2023-03572: Combination Chemotherapy (FLAG-Ida) With Pivekimab Sunirine (PVEK [IMGN632]) for the Treatment of Newly Diagnosed Adverse Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms (clinicaltrials.gov)
    P1, N=30, Recruiting, Fred Hutchinson Cancer Center | Trial completion date: Dec 2027 --> Dec 2029
    Trial completion date
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    Chr t(15;17)
    |
    cytarabine • idarubicin hydrochloride • fludarabine IV • Decnupaz (pivekimab sunirine-pvzy) • Starasid (cytarabine ocfosfate)
    4ms
    Pivekimab Sunirine in Blastic Plasmacytoid Dendritic Cell Neoplasm. (PubMed, J Clin Oncol)
    PVEK, with convenient dosing, led to high, durable responses, especially in frontline BPDCN, and a manageable safety profile.
    Clinical • Journal
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    Decnupaz (pivekimab sunirine-pvzy)
    4ms
    Study of AZD9829 in CD123+ Hematological Malignancies (clinicaltrials.gov)
    P1/2, N=56, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting | N=104 --> 56 | Trial completion date: Jan 2027 --> Mar 2026 | Trial primary completion date: Jan 2027 --> Oct 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    5ms
    BYON4413.001: Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms. (clinicaltrials.gov)
    P1, N=16, Active, not recruiting, Byondis B.V. | Recruiting --> Active, not recruiting | N=100 --> 16 | Trial completion date: Mar 2027 --> Feb 2026 | Trial primary completion date: Dec 2026 --> Sep 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • First-in-human
    |
    BYON4413
    5ms
    A Study to Assess Adverse Events and How Intravenous (IV) Pivekimab Sunirine Moves Through the Body in Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, AbbVie
    New P1 trial • Adverse events
    |
    Decnupaz (pivekimab sunirine-pvzy)
    10ms
    Study of AZD9829 in CD123+ Hematological Malignancies (ChiCTR2500104541)
    P1/2, N=132, Recruiting, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.; Institute of Hematolog
    New P1/2 trial
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)