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    DRUG:

    emavusertib (CA-4948)

    i
    Other names: CA-4948, AU 4948, CA 4948, AU-4948, CA4948, AU4948
    Company:
    Aurigene, Curis, Dr. Reddy’s
    Drug class:
    IRAK-4 inhibitor
    Related drugs:
    2ms
    Improving Immune Checkpoint Blockade Efficacy in Melanoma Brain Metastases through Myddosomal inhibition with Emavusertib. (PubMed, Mol Cancer Ther)
    Emavusertib in combination with anti-PD-1 therapy results in improved tumor-infiltrating lymphocyte recruitment, decreased myeloid derived suppressor cell function, and upregulation of interferon γ signaling resulting in improved survival in aggressive mouse models of melanoma brain metastases. This work supports the development of combination strategies of emavusertib with immune checkpoint blockade in melanoma brain metastases.
    Journal • Checkpoint inhibition
    |
    MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • IFNG (Interferon, gamma) • IRAK4 (Interleukin 1 Receptor Associated Kinase 4)
    |
    emavusertib (CA-4948)
    3ms
    CA-4948 Added to Standard Chemotherapy to Treat Metastatic or Unresectable Pancreatic Cancer (clinicaltrials.gov)
    P1, N=43, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension
    |
    gemcitabine • albumin-bound paclitaxel • emavusertib (CA-4948)
    3ms
    CA-4948 Added to Standard Chemotherapy to Treat Metastatic or Unresectable Pancreatic Cancer (clinicaltrials.gov)
    P1, N=43, Recruiting, National Cancer Institute (NCI) | Trial completion date: Apr 2026 --> Apr 2027 | Trial primary completion date: Apr 2026 --> Apr 2027
    Trial completion date • Trial primary completion date
    |
    gemcitabine • albumin-bound paclitaxel • emavusertib (CA-4948)
    3ms
    CA-4948 in Combination With FOLFOX/PD-1 Inhibitor +/- Trastuzumab for Untreated Unresectable Gastric and Esophageal Cancer (clinicaltrials.gov)
    P1, N=42, Recruiting, Washington University School of Medicine | Trial completion date: Jun 2028 --> Apr 2029 | Trial primary completion date: Sep 2027 --> Jul 2028
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Herceptin (trastuzumab) • 5-fluorouracil • leucovorin calcium • emavusertib (CA-4948)
    4ms
    Emavusertib (CA-4948) in Combination With Cisplatin, Gemcitabine, and Durvalumab in Patients With Untreated Advanced or Metastatic Biliary Tract Cancer (clinicaltrials.gov)
    P1, N=48, Recruiting, Washington University School of Medicine | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • emavusertib (CA-4948)
    5ms
    CA-4948 102: Dose Escalation/ Expansion Study of CA-4948 as Monotherapy in Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov)
    P1/2, N=366, Suspended, Curis, Inc. | Recruiting --> Suspended
    Trial suspension • IO biomarker
    |
    FLT3 (Fms-related tyrosine kinase 3) • SF3B1 (Splicing Factor 3b Subunit 1) • U2AF1 (U2 Small Nuclear RNA Auxiliary Factor 1)
    |
    FLT3 mutation • SF3B1 mutation
    |
    Venclexta (venetoclax) • emavusertib (CA-4948)
    5ms
    CA-4948-203: A Ph2 Study of Emavusertib + an Approved BTKi in Patients with CLL and Other B-cell Malignancies (2025-523600-68-00)
    P1/2, N=40, Not yet recruiting, Curis Inc.
    New P1/2 trial
    |
    clonoSEQ®
    |
    Brukinsa (zanubrutinib) • emavusertib (CA-4948)
    5ms
    A Trial Comparing Three Different Treatment Options for Adults With Low-Risk Myelodysplasia and Anemia (A MyeloMATCH Treatment Trial) (clinicaltrials.gov)
    P2, N=270, Not yet recruiting, National Cancer Institute (NCI)
    New P2 trial
    |
    emavusertib (CA-4948) • Reblozyl (luspatercept-aamt) • Retacrit (epoetin alfa-epbx)
    5ms
    CA-4948-104: A Ph1 Study of Emavusertib in AML CR MRD+ Patients Currently Receiving Azacitidine and Venetoclax (2023-505828-58-00)
    P1, N=24, Active, not recruiting, Curis Inc. | -> Active, not recruiting | Phase classification: PN/A --> P1
    Enrollment closed • Phase classification
    |
    Venclexta (venetoclax) • azacitidine • emavusertib (CA-4948)
    6ms
    A Study of Emavusertib + An Approved Bruton Tyrosine Kinase Inhibitor (BTKi) in Participants With Chronic Lymphocytic Leukemia (CLL) and Other B-cell Malignancies (clinicaltrials.gov)
    P2, N=108, Recruiting, Curis, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    clonoSEQ®
    |
    Brukinsa (zanubrutinib) • emavusertib (CA-4948)
    8ms
    A Study of Emavusertib + An Approved Bruton Tyrosine Kinase Inhibitor (BTKi) in Participants With Chronic Lymphocytic Leukemia (CLL) and Other B-cell Malignancies (clinicaltrials.gov)
    P2, N=108, Not yet recruiting, Curis, Inc.
    New P2 trial
    |
    Brukinsa (zanubrutinib) • emavusertib (CA-4948)
    8ms
    CA-4948 in Combination With Cisplatin, Gemcitabine, and Durvalumab in Patients With Untreated Advanced or Metastatic Biliary Tract Cancer (clinicaltrials.gov)
    P1, N=48, Not yet recruiting, Washington University School of Medicine | Trial completion date: Dec 2031 --> Apr 2032 | Initiation date: Oct 2025 --> Feb 2026 | Trial primary completion date: Jan 2030 --> May 2030
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • emavusertib (CA-4948)