^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    torvutatug samrotecan (AZD5335)

    i
    Other names: AZD5335, AZD-5335, AZD 5335
    Company:
    AstraZeneca
    Drug class:
    Topoisomerase I inhibitor, Folate receptor 1-targeted antibody-drug conjugate
    Related drugs:
    1m
    TREVI-OC-01: AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer (clinicaltrials.gov)
    P3, N=1100, Recruiting, AstraZeneca | N=309 --> 1100
    Enrollment change • Trial initiation date • Platinum resistant
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    paclitaxel • pegylated liposomal doxorubicin • Elahere (mirvetuximab soravtansine-gynx) • topotecan • torvutatug samrotecan (AZD5335)
    2ms
    TREVI-OC-01: AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer (clinicaltrials.gov)
    P3, N=289, Recruiting, AstraZeneca | N=46 --> 289
    Enrollment change • Platinum resistant
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    paclitaxel • pegylated liposomal doxorubicin • Elahere (mirvetuximab soravtansine-gynx) • topotecan • torvutatug samrotecan (AZD5335)
    2ms
    D8991C00001: AZD5335 vs. Mirvetuximab Soravtansine in FR?-high and AZD5335 vs. Chemotherapy in FR?-low Platinum-resistant Ovarian Cancer (TREVI-OC-01) (2025-520466-22-00)
    P2/3, N=46, Not yet recruiting, AstraZeneca AB
    New P2/3 trial • Platinum resistant
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    paclitaxel • Elahere (mirvetuximab soravtansine-gynx) • topotecan • torvutatug samrotecan (AZD5335)
    4ms
    D8991C00002: A trial to learn how safe AZD5335 is and if a drug called itraconazole changes how AZD5335 moves through the body over time in adults with ovarian, peritoneal, or fallopian tube cancer (2025-522731-34-00)
    P1, N=34, Recruiting, AstraZeneca AB
    New P1 trial
    |
    itraconazole • torvutatug samrotecan (AZD5335)
    4ms
    Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov)
    P1, N=24, Recruiting, AstraZeneca
    New P1 trial
    |
    itraconazole • torvutatug samrotecan (AZD5335)
    5ms
    TREVI-OC-01: AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer (clinicaltrials.gov)
    P3, N=1100, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open • Platinum resistant
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    paclitaxel • pegylated liposomal doxorubicin • Elahere (mirvetuximab soravtansine-gynx) • topotecan • torvutatug samrotecan (AZD5335)
    8ms
    TREVI-OC-01: AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer (clinicaltrials.gov)
    P3, N=1100, Not yet recruiting, AstraZeneca
    New P3 trial • Platinum resistant
    |
    paclitaxel • pegylated liposomal doxorubicin • Elahere (mirvetuximab soravtansine-gynx) • topotecan • torvutatug samrotecan (AZD5335)
    8ms
    Derivation of AZD5335, a novel FRα-targeted TOP1i-loaded ADC, for the treatment of FRα-expressing cancers. (PubMed, Clin Cancer Res)
    AZD5335 is a promising next-generation ADC capable of targeting ovarian cancers with both high and low FRα expression. AZD5335 demonstrates efficacy in overcoming Elahere-resistance and supports combined treatment strategies.
    Journal • PARP Biomarker
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression
    |
    Elahere (mirvetuximab soravtansine-gynx) • torvutatug samrotecan (AZD5335)
    over1year
    FONTANA: Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors (clinicaltrials.gov)
    P1/2, N=396, Recruiting, AstraZeneca | N=150 --> 396
    Enrollment change
    |
    Avastin (bevacizumab) • carboplatin • saruparib (AZD5305) • torvutatug samrotecan (AZD5335)
    almost3years
    FONTANA: A phase I/IIa study of AZD5335 as monotherapy and in combination with anti-cancer agents in patients with solid tumours (ESMO 2023)
    The study will evaluate AZD5335 as monotherapy in patients with ovarian cancer or lung adenocarcinoma (Module 1), or AZD5335 in combination with AZD5305, a selective poly(ADP-ribose) polymerase 1 inhibitor, in patients with ovarian cancer (Module 2). Secondary objectives include assessment of objective response rate, duration of response, disease control rate, and progression-free survival by RECIST v1.1, and overall survival; characterising the pharmacokinetics of AZD5335 when given as monotherapy or in combination; and assessing immunogenicity. The study will be open to recruitment by 25 May 2023.
    Clinical • P1/2 data • Combination therapy
    |
    FOLR1 ( Folate receptor alpha )
    |
    saruparib (AZD5305) • torvutatug samrotecan (AZD5335)
    almost3years
    FONTANA: Phase I/IIa Study for AZD5335 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Solid Tumors (clinicaltrials.gov)
    P1/2, N=150, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    MUC16 (Mucin 16, Cell Surface Associated)
    |
    saruparib (AZD5305) • torvutatug samrotecan (AZD5335)
    3years
    FONTANA: Phase I/IIa Study for AZD5335 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Solid Tumors (clinicaltrials.gov)
    P1/2, N=150, Not yet recruiting, AstraZeneca
    New P1/2 trial • Combination therapy
    |
    MUC16 (Mucin 16, Cell Surface Associated)
    |
    saruparib (AZD5305) • torvutatug samrotecan (AZD5335)