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    DRUG:

    rinatabart sesutecan (PRO1184)

    i
    Other names: PRO1184, Rina-S
    Company:
    Genmab
    Drug class:
    Topoisomerase I inhibitor, Folate receptor 1-targeted antibody-drug conjugate
    Related drugs:
    2ms
    Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer (clinicaltrials.gov)
    P3, N=530, Not yet recruiting, Genmab
    New P3 trial
    |
    gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • rinatabart sesutecan (PRO1184)
    7ms
    PRO1184-001: PRO1184 for Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=374, Recruiting, ProfoundBio US Co. | N=134 --> 374 | Trial completion date: Sep 2025 --> Apr 2026 | Trial primary completion date: Jan 2025 --> Oct 2025
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • FOLR1 ( Folate receptor alpha )
    |
    HR positive • HER-2 negative • FOLR1 expression • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • carboplatin • rinatabart sesutecan (PRO1184)
    1year
    A phase 1/2 study of rinatabart sesutecan (PRO1184), a novel folate receptor alpha-directed antibody-drug conjugate, in patients with locally advanced and/or metastatic solid tumors (SITC 2023)
    Antitumor activity has been observed at well tolerated dose levels. Dose escalation continues.
    P1/2 data • Clinical • Metastases
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression
    |
    VENTANA FOLR1 RxDx Assay
    |
    rinatabart sesutecan (PRO1184)
    over1year
    Phase 1/2 study of PRO1184, a novel folate receptor alpha-directed antibody-drug conjugate, in patients with locally advanced and/or metastatic solid tumors. (ASCO 2023)
    The study is currently enrolling at sites in the US, with future enrollment in China planned (NCT05579366). Clinical trial information: NCT05579366.
    Clinical • P1/2 data • Metastases
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression
    |
    rinatabart sesutecan (PRO1184)
    over1year
    Phase 1/2 study of PRO1184, a novel folate receptor alpha-directed antibody-drug conjugate, in patients with locally advanced and/or metastatic solid tumors (AACR 2023)
    PK, immunogenicity, and antitumor activity will also be evaluated. The study is currently enrolling at sites in the US, with future enrollment in China planned (NCT05579366).
    Clinical • P1/2 data • Metastases
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression
    |
    rinatabart sesutecan (PRO1184)
    over1year
    Novel folate receptor alpha-directed antibody-drug conjugate PRO1184 demonstrates broad antitumor activity with a promising safety profile in preclinical models (AACR 2023)
    In summary, PRO1184 is a promising development candidate for the treatment of FRα-expressing solid tumors. A first in human phase 1/2 study in patients with advanced solid tumors is currently recruiting (NCT 05579366).
    Preclinical
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression
    |
    rinatabart sesutecan (PRO1184)
    almost2years
    PRO1184, a Novel, Exatecan- Based, Folate Receptor Alpha Directed ADC, for Patients With Advanced Solid Tumour Cancers (ADC London 2023)
    • Discussing the exciting potential of PRO1184, as it is expected to be active in ovarian, endometrial, nonsmall cell lung, and breast cancer, and mesothelioma • Outlining novel hydrophilic linker confers optimal PK/PD properties and potential for wide therapeutic window • Describing efficient clinical trial design based on PRO1184 attributes
    Clinical • Metastases
    |
    FOLR1 ( Folate receptor alpha )
    |
    rinatabart sesutecan (PRO1184)
    2years
    PRO1184-001: PRO1184 for Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=134, Recruiting, ProfoundBio US Co. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • FOLR1 ( Folate receptor alpha )
    |
    HR positive • HER-2 negative • FOLR1 expression • HR positive + HER-2 negative
    |
    rinatabart sesutecan (PRO1184)
    2years
    PRO1184-001: PRO1184 for Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=134, Not yet recruiting, ProfoundBio US Co.
    New P1/2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • FOLR1 ( Folate receptor alpha )
    |
    HR positive • HER-2 negative • FOLR1 expression • HR positive + HER-2 negative
    |
    rinatabart sesutecan (PRO1184)
    over2years
    PRO1184, a novel folate receptor alpha-directed antibody-drug conjugate, demonstrates robust anti-tumor activity in mouse carcinoma models (AACR 2022)
    The pharmacokinetics (PK) of PRO1184 were similar to that of the unconjugated parent antibody in rats. PRO1184 has the potential for a meaningful therapeutic window to provide an appropriate benefit to risk profile for patients with FOLR1-expressing cancers.
    Preclinical
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression • FOLR1 overexpression
    |
    rinatabart sesutecan (PRO1184)