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    DRUG CLASS:

    IL1RAP inhibitor

    Related drugs:
    12d
    A single-dose escalation study to evaluate the safety, tolerability and pharmacokinetic characteristics of the first human administration of IBI3011 (ChiCTR2500113653)
    P1, N=64, Recruiting, The First Affiliated Hospital of Soochow University; Innovent Biologics (Suzhou) Co., Ltd.
    New P1 trial
    22d
    CLAROS: A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov)
    P2, N=144, Recruiting, Sanofi | Not yet recruiting --> Recruiting
    Enrollment open
    2ms
    A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic of IBI3011 (clinicaltrials.gov)
    P1, N=64, Recruiting, Innovent Biologics (Suzhou) Co. Ltd.
    New P1 trial
    3ms
    Single and Multiple Ascending Dose Study in Healthy Participants and Participants With an Autoimmune Disease (clinicaltrials.gov)
    P1, N=69, Completed, Almirall, S.A. | Recruiting --> Completed | Trial completion date: Dec 2024 --> Apr 2025 | Trial primary completion date: Dec 2024 --> Apr 2025
    Trial completion • Trial completion date • Trial primary completion date
    3ms
    CLAROS: A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov)
    P2, N=144, Not yet recruiting, Sanofi
    New P2 trial
    5ms
    A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML) (clinicaltrials.gov)
    P1/2, N=40, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Venclexta (venetoclax) • azacitidine • nadunolimab (CAN04)
    5ms
    A Study of LAD191 in Adults With Hidradenitis Suppurativa (clinicaltrials.gov)
    P2, N=200, Not yet recruiting, Almirall, S.A.
    New P2 trial
    7ms
    Safety, efficacy, and analysis of biomarkers in patients with advanced non-small cell lung cancer treated with the anti-IL1RAP antibody nadunolimab (CAN04) in combination with platinum doublet. (PubMed, Lung Cancer)
    Nadunolimab plus platinum-based doublet chemotherapies showed promising efficacy in advanced NSCLC, with the greatest benefit in patients with non-squamous histology treated in second line after relapsing on pembrolizumab treatment.
    Journal • PD(L)-1 Biomarker
    |
    IL1B (Interleukin 1, beta) • IL1RAP (Interleukin 1 Receptor Accessory Protein)
    |
    Keytruda (pembrolizumab) • nadunolimab (CAN04)
    10ms
    Safety, tolerability, and preliminary efficacy of nadunolimab, an anti-IL- 1 receptor accessory protein monoclonal antibody, in combination with pembrolizumab in patients with solid tumors. (PubMed, Invest New Drugs)
    Nadunolimab with pembrolizumab had an acceptable safety profile, and prolonged disease control was observed in a subset of patients. The results support further development of nadunolimab in combination with checkpoint inhibitors.
    Journal
    |
    IL6 (Interleukin 6) • CD163 (CD163 Molecule) • IL1B (Interleukin 1, beta) • IL1RAP (Interleukin 1 Receptor Accessory Protein)
    |
    Keytruda (pembrolizumab) • nadunolimab (CAN04)
    11ms
    TRIFOUR: Nadunolimab in Combination with Gemcitabine Plus Carboplatin in Patients with Advanced Triple Negative Breast Cancer. (clinicaltrials.gov)
    P1/2, N=117, Active, not recruiting, Cantargia AB | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    HER-2 negative • HER-2 negative + HR negative • HER-2 negative + HR negative + BRCA mutation
    |
    PD-L1 IHC 22C3 pharmDx • Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    carboplatin • gemcitabine • nadunolimab (CAN04)
    1year
    Blocking IL1RAP on cancer-associated fibroblasts in pancreatic ductal adenocarcinoma suppresses IL-1-induced neutrophil recruitment. (PubMed, J Immunother Cancer)
    Our study demonstrates that targeting IL1RAP on CAFs inhibits IL-1-induced chemokine secretion and recruitment of neutrophils and monocytes, thereby counteracting the immunosuppressive microenvironment in PDAC. These findings highlight the therapeutic potential of targeting IL1RAP in PDAC.
    Journal
    |
    IL1B (Interleukin 1, beta) • IL1RAP (Interleukin 1 Receptor Accessory Protein)
    |
    nadunolimab (CAN04)
    over1year
    TRIFOUR: Nadunolimab in Combination with Gemcitabine Plus Carboplatin in Patients with Advanced Triple Negative Breast Cancer. (clinicaltrials.gov)
    P1/2; Trial primary completion date: Aug 2026 --> Jun 2025
    Combination therapy • Trial primary completion date • BRCA Companion diagnostic • PARP Companion diagnostic • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    BRCA2 mutation • BRCA1 mutation • HER-2 negative • HER-2 negative + HR negative • HER-2 negative + HR negative + BRCA mutation
    |
    PD-L1 IHC 22C3 pharmDx • Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    carboplatin • gemcitabine • nadunolimab (CAN04)