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    DRUG:

    puxitatug samrotecan (AZD8205)

    i
    Other names: AZD8205, AZD-8205, AZD 8205
    Company:
    AstraZeneca
    Drug class:
    Topoisomerase I inhibitor, B7-H4-targeted antibody-drug conjugate
    Related drugs:
    10d
    BLUESTAR: A Phase I/IIa Study of AZD8205 Given Alone or in Combination With Anticancer Drugs, in Participants With Advanced or Metastatic Solid Malignancies (clinicaltrials.gov)
    P1/2, N=340, Recruiting, AstraZeneca | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Dec 2025 --> Jun 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    puxitatug samrotecan (AZD8205) • rilvegostomig (AZD2936)
    2ms
    Extensive Biotransformation Profiling of AZD8205, an Anti-B7-H4 Antibody-Drug Conjugate, Elucidates Pathways Underlying Its Stability In Vivo. (PubMed, Anal Chem)
    The comprehensive nature of this work increases our confidence in the understanding of these processes. We hope this analytical approach can inform future development of bioconjugate drug candidates.
    Preclinical • Journal
    |
    VTCN1 (V-Set Domain Containing T Cell Activation Inhibitor 1)
    |
    puxitatug samrotecan (AZD8205)
    6ms
    A Phase I/IIa Study of AZD8205 Given Alone or in Combination With Anticancer Drugs, in Participants With Advanced or Metastatic Solid Malignancies (clinicaltrials.gov)
    P1/2, N=340, Recruiting, AstraZeneca | N=248 --> 340 | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Jun 2025 --> Dec 2025
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    puxitatug samrotecan (AZD8205) • rilvegostomig (AZD2936)
    over1year
    Spatial Immunoprofiling of Adenoid Cystic Carcinoma Reveals B7-H4 Is a Therapeutic Target for Aggressive Tumors. (PubMed, Clin Cancer Res)
    Spatial analysis revealed that ACC subtypes have distinct TMEs, with enrichment of ACC-I immune cells that are restricted to the stroma. B7-H4 is highly expressed in poor-prognosis ACC-I subtype and is a potential therapeutic target.
    Journal
    |
    VTCN1 (V-Set Domain Containing T Cell Activation Inhibitor 1)
    |
    VTCN1 underexpression
    |
    puxitatug samrotecan (AZD8205)
    almost2years
    Preclinical evaluation of a novel B7-H4 targeted antibody-drug conjugate AZD8205 as a single agent and in combination with novel PARP inhibitor and checkpoint blockade (AACR 2023)
    To further exploit the DNA damage elicited by the specific delivery of the TOP1i warhead, the combination of AZD8205 with a novel poly-ADP ribose polymerase 1 (PARP1) selective inhibitor, AZD5305, was investigated. These data demonstrate that AZD8205 is a promising therapeutic candidate for the treatment of B7-H4 positive solid tumors. A first in human phase I/IIa study in patients with advanced solid tumors is currently ongoing (NCT05123482).
    Preclinical • Combination therapy • Checkpoint inhibition • PARP Biomarker • PD(L)-1 Biomarker • IO biomarker • Checkpoint block
    |
    HRD (Homologous Recombination Deficiency) • VTCN1 (V-Set Domain Containing T Cell Activation Inhibitor 1)
    |
    VTCN1 underexpression
    |
    puxitatug samrotecan (AZD8205) • saruparib (AZD5305)
    over2years
    First-in-human study of the B7-H4 antibody-drug conjugate (ADC) AZD8205 in patients with advanced/metastatic solid tumors. (ASCO 2022)
    Secondary objectives include assessing initial activity (objective response and progression-free survival by RECIST v1.1, and overall survival), pharmacodynamics, pharmacokinetics, and immunogenicity. The trial is currently recruiting and will enroll patients globally.
    Clinical • P1 data
    |
    VTCN1 (V-Set Domain Containing T Cell Activation Inhibitor 1)
    |
    VTCN1 underexpression
    |
    puxitatug samrotecan (AZD8205)
    almost3years
    Discovery and first disclosure of AZD8205, a B7-H4-targeted antibody-drug conjugate utilizing a novel topoisomerase I linker-warhead (AACR 2022)
    These data suggest that AZD8205 is a promising therapeutic candidate for the treatment of B7-H4 positive solid tumors. A first in human phase 1 study in patients with advanced solid tumors is currently ongoing (NCT05123482).
    BRCA Biomarker • PARP Biomarker
    |
    BRCA (Breast cancer early onset) • VTCN1 (V-Set Domain Containing T Cell Activation Inhibitor 1)
    |
    BRCA wild-type • VTCN1 underexpression
    |
    puxitatug samrotecan (AZD8205)