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    DRUG:

    225Ac-vipivotide tetraxetan (AAA817)

    i
    Other names: AAA817, 225 Actinium PSMA 617, 225Ac-PSMA-617, 225Ac PSMA 617, AAA 817, AAA-817
    Associations

    News

    Trials
    Company:
    Novartis
    Drug class:
    Alpha radiation emitter, PSMA inhibitor
    Related drugs:
    Associations

    News

    Trials
    12d
    PSMA-617-100: Study of 225Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer (clinicaltrials.gov)
    P1, N=101, Active, not recruiting, Endocyte | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    FOLH1 positive
    |
    abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • 225Ac-vipivotide tetraxetan (AAA817)
    3ms
    AcTFirst: Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC (clinicaltrials.gov)
    P3, N=940, Recruiting, Novartis Pharmaceuticals | Trial primary completion date: Feb 2028 --> Sep 2028
    Trial primary completion date
    |
    HRD (Homologous Recombination Deficiency)
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • cabazitaxel • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • 225Ac-vipivotide tetraxetan (AAA817)
    4ms
    AcTFirst: Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC (clinicaltrials.gov)
    P3, N=940, Recruiting, Novartis Pharmaceuticals | Trial primary completion date: Sep 2028 --> Feb 2028
    Trial primary completion date
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • cabazitaxel • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • 225Ac-vipivotide tetraxetan (AAA817)
    5ms
    AcTFirst: Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC (clinicaltrials.gov)
    P3, N=940, Recruiting, Novartis Pharmaceuticals | N=605 --> 940 | Trial primary completion date: Feb 2028 --> Sep 2028
    Enrollment change • Trial primary completion date
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • cabazitaxel • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • 225Ac-vipivotide tetraxetan (AAA817)
    5ms
    ANDROMEDA: Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma (clinicaltrials.gov)
    P2, N=107, Recruiting, Jonsson Comprehensive Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • 225Ac-vipivotide tetraxetan (AAA817)
    6ms
    PSMAcTION: Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy (clinicaltrials.gov)
    P2/3, N=432, Recruiting, Novartis Pharmaceuticals | Trial completion date: Apr 2033 --> Jul 2033 | Trial primary completion date: Mar 2028 --> Jun 2028
    Trial completion date • Trial primary completion date
    |
    225Ac-vipivotide tetraxetan (AAA817)
    8ms
    ANDROMEDA: Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma (clinicaltrials.gov)
    P2, N=107, Not yet recruiting, Jonsson Comprehensive Cancer Center
    New P2 trial
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • 225Ac-vipivotide tetraxetan (AAA817)
    10ms
    AcTFirst: Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC (clinicaltrials.gov)
    P3, N=605, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • cabazitaxel • 225Ac-vipivotide tetraxetan (AAA817)
    1year
    AcTFirst: Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC (clinicaltrials.gov)
    P3, N=486, Not yet recruiting, Novartis Pharmaceuticals
    New P3 trial
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • cabazitaxel • 225Ac-vipivotide tetraxetan (AAA817)
    1year
    PSMAcTION: Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy (clinicaltrials.gov)
    P2/3, N=432, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open
    |
    225Ac-vipivotide tetraxetan (AAA817)
    over1year
    PSMAcTION: Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy (clinicaltrials.gov)
    P2/3, N=432, Not yet recruiting, Novartis Pharmaceuticals
    New P2/3 trial
    |
    225Ac-vipivotide tetraxetan (AAA817)
    over1year
    PSMA-617-100: Study of 225Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer (clinicaltrials.gov)
    P1, N=99, Recruiting, Endocyte | N=60 --> 99
    Enrollment change
    |
    abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • 225Ac-vipivotide tetraxetan (AAA817)