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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:
    6d
    GCT1184-03: Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigators Choice in Participants With Endometrial Cancer ( RAINFOL-03 ) (2024-519818-31-01)
    P2/3, N=98, Not yet recruiting, Genmab A/S
    New P2/3 trial
    |
    paclitaxel • doxorubicin hydrochloride • Rina-S (rinatabart sesutecan)
    9d
    GCT1184-03: Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigators Choice in Participants With Endometrial Cancer ( RAINFOL-03 ) (2024-519818-31-01)
    P2/3, N=51, Not yet recruiting, Genmab A/S
    New P2/3 trial
    |
    paclitaxel • doxorubicin hydrochloride • 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, Active, not recruiting, Genmab | Recruiting --> Active, not recruiting
    Enrollment closed • Platinum resistant
    |
    FOLR1 ( Folate receptor alpha ) • BRCA (Breast cancer early onset)
    |
    FOLR1 expression • BRCA mutation
    |
    gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • Rina-S (rinatabart sesutecan)
    2ms
    RAINFOL-05: Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=240, Recruiting, Genmab | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Rina-S (rinatabart sesutecan)
    3ms
    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, Recruiting, Genmab | Not yet recruiting --> Recruiting
    Enrollment open • Platinum sensitive
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    Avastin (bevacizumab) • Rina-S (rinatabart sesutecan)
    4ms
    RAINFOL-05: Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=240, Not yet recruiting, Genmab
    New P2 trial
    |
    Rina-S (rinatabart sesutecan)
    4ms
    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, Recruiting, Genmab | Not yet recruiting --> Recruiting
    Enrollment open
    |
    paclitaxel • doxorubicin hydrochloride • Rina-S (rinatabart sesutecan)
    4ms
    RAINFOL-01: Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001) (clinicaltrials.gov)
    P1/2, N=764, Recruiting, Genmab | N=569 --> 764
    Enrollment change
    |
    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)
    5ms
    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)
    6ms
    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)
    7ms
    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)
    12ms
    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)