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    DRUG:

    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)

    i
    Other names: 177 Lu PSMA-617, Lu177-PSMA-617, Lu177 RLT, 177LU-PSMA-617, PSMA-617, 177lutetium-PSMA-617, AAA617, AAA-617, AAA 617
    Company:
    Novartis, Otsuka
    Drug class:
    Beta radiation emitter, PSMA inhibitor
    Related drugs:
    2d
    Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial (clinicaltrials.gov)
    P2, N=202, Not yet recruiting, Mayo Clinic
    New P2 trial
    |
    abiraterone acetate • Eligard (leuprolide acetate) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Viadur (leuprorelin implant) • Yonsa (abiraterone acetate)
    2d
    Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial (clinicaltrials.gov)
    P3, N=1524, Recruiting, Alliance for Clinical Trials in Oncology | Not yet recruiting --> Recruiting | Initiation date: Oct 2025 --> Mar 2026
    Enrollment open • Trial initiation date
    |
    FOLH1 positive
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    3d
    Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function (clinicaltrials.gov)
    P2, N=23, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | Trial completion date: Jun 2026 --> Dec 2026 | Trial primary completion date: Jun 2026 --> Dec 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    6d
    Natural Flavonoids Genistein and Baicalein as Well-Tolerated Radiosensitizers to Enhance the Efficacy of 177Lu-PSMA617 in Prostate Cancer: In Vitro and In Vivo Studies. (PubMed, Research (Wash D C))
    Their natural origin and established safety profile underscore their translational potential. Thus, genistein and baicalein represent promising novel adjuvants for prostate cancer radioligand therapy.
    Preclinical • Journal
    |
    CASP3 (Caspase 3)
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    7d
    Phase I Study of 225Ac-J591 Plus 177Lu-PSMA Small Molecule for Progressive Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=42, Recruiting, Weill Medical College of Cornell University | N=20 --> 42 | Active, not recruiting --> Recruiting
    Enrollment open • Enrollment change
    |
    CELLSEARCH®
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Ac-225 rosopatamab tetraxetan (CONV01-α)
    7d
    Effects of androgen receptor signaling inhibitors on absorbed doses in mCRPC patients undergoing [177Lu]Lu-PSMA-617 or [177Lu]Lu-PSMA-I&T therapy: dosimetry results. (PubMed, Eur J Nucl Med Mol Imaging)
    In this pilot cohort, concomitant ARSi therapy did not significantly enhance tumor absorbed doses in patients receiving [177Lu]Lu-PSMA-617 or [177Lu]Lu-PSMA-I&T RLT. Further prospective studies with larger patient numbers are needed to evaluate the impact of concomitant ARSi treatment on the absorbed doses in mCRPC tumor lesions.
    Journal
    |
    FOLH1 (Folate hydrolase 1) • ARSI (Arylsulfatase Family Member I)
    |
    FOLH1 expression
    |
    enzalutamide • abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    9d
    Lanmodulin-Engineered Outer Membrane Vesicles for Synergistic Targeted Radio-Immunotherapy. (PubMed, ACS Nano)
    In a head-to-head comparison with clinically approved 177Lu-PSMA-617 (Pluvicto), PSMA-targeted TRT@LnOMVs achieved a 90% survival rate in a prostate cancer model, far surpassing the 25% survival rate of Pluvicto...This occurred through reprogramming immunosuppressive myeloid compartments (including neutrophil subsets and macrophages), expanding cytotoxic CD8+ T and NK cell infiltration, and activating innate immunity to trigger robust antitumor responses. Collectively, TRT@LnOMVs represent a versatile class of biohybrid therapeutics, offering a robust paradigm for next-generation radio-immunotherapy.
    Journal
    |
    CD8 (cluster of differentiation 8)
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    10d
    CaboLu: Dose-Escalation Study of Cabozantinib in Combination With Lutetium-177 (177Lu)-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=33, Suspended, University of Utah | Trial completion date: May 2028 --> Dec 2028 | Recruiting --> Suspended | Trial primary completion date: May 2026 --> Dec 2026
    Trial completion date • Trial suspension • Trial primary completion date
    |
    FOLH1 positive
    |
    Cabometyx (cabozantinib tablet) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    10d
    A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive mCRPC (clinicaltrials.gov)
    P2, N=62, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed
    Trial completion
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    14d
    RENALUT: Radiopharmaceutical Treatment of Advanced Kidney Cancer (clinicaltrials.gov)
    P2, N=48, Recruiting, European Organisation for Research and Treatment of Cancer - EORTC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    FOLH1 positive
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • lutetium zadavotide guraxetan (PNT2002)
    15d
    PLUVIPAC: Experience of 177Lu-PSMA-617-administration on Port Reservoir (TIVAP) (clinicaltrials.gov)
    P=N/A, N=107, Completed, Central Hospital, Nancy, France | Recruiting --> Completed
    Trial completion
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    15d
    ZENITH: Zanzalintinib Efficacy Post Pluvicto® in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Stuthi Perimbeti
    New P2 trial
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • zanzalintinib (XL092)