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    DRUG:

    Rina-S (rinatabart sesutecan)

    i
    Other names: PRO1184, GEN1184, GEN-1184
    Company:
    Genmab
    Drug class:
    Topoisomerase I inhibitor, Folate receptor 1-targeted antibody-drug conjugate
    Related drugs:
    29d
    RAINFOL-04: Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care for Maintenance Treatment of Participants With Recurrent Platinum-sensitive Ovarian Cancer After Second-line (2L) Platinum-based Doublet Chemotherapy (clinicaltrials.gov)
    P3, N=528, Not yet recruiting, Genmab
    New P3 trial • Platinum sensitive
    |
    Avastin (bevacizumab) • Rina-S (rinatabart sesutecan)
    1m
    RAINFOL-02: 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, Recruiting, Genmab | Trial primary completion date: May 2027 --> Feb 2027
    Trial primary completion date • Platinum resistant
    |
    gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • Rina-S (rinatabart sesutecan)
    3ms
    RAINFOL-03: Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer (clinicaltrials.gov)
    P3, N=544, Not yet recruiting, Genmab
    New P3 trial
    |
    paclitaxel • doxorubicin hydrochloride • Rina-S (rinatabart sesutecan)
    8ms
    ENCORE: Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001) (clinicaltrials.gov)
    P1/2, N=529, Recruiting, Genmab | N=404 --> 529 | Trial completion date: Oct 2026 --> Sep 2027 | Trial primary completion date: Apr 2026 --> Jun 2027
    Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • FOLR1 ( Folate receptor alpha )
    |
    HR positive • HER-2 negative • FOLR1 expression • HR positive + HER-2 negative
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • carboplatin • Rina-S (rinatabart sesutecan)
    11ms
    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, Recruiting, Genmab | Not yet recruiting --> Recruiting
    Enrollment open
    |
    gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • Rina-S (rinatabart sesutecan)
    11ms
    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 | Trial completion date: Nov 2029 --> Apr 2028 | Trial primary completion date: Feb 2027 --> May 2027
    Trial completion date • Trial primary completion date
    |
    gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • Rina-S (rinatabart sesutecan)
    11ms
    Rinatabart Sesutecan (Rina-S) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001) (clinicaltrials.gov)
    P1/2, N=404, Recruiting, Genmab | Trial completion date: Apr 2026 --> Oct 2026 | Trial primary completion date: Oct 2025 --> Apr 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • FOLR1 ( Folate receptor alpha )
    |
    HR positive • HER-2 negative • FOLR1 expression • HR positive + HER-2 negative
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • carboplatin • Rina-S (rinatabart sesutecan)
    1year
    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 • Rina-S (rinatabart sesutecan)
    over1year
    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 • Rina-S (rinatabart sesutecan)
    2years
    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
    |
    Rina-S (rinatabart sesutecan)
    over2years
    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
    |
    Rina-S (rinatabart sesutecan)
    over2years
    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
    |
    Rina-S (rinatabart sesutecan)