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    BIOMARKER:

    FOLH1 positive

    i
    Other names: FOLH1, FOLH, GCP2, GCPII, NAALAD1, NAALAdase, PSM, PSMA, Folate hydrolase 1, prostate-specific membrane antigen
    Entrez ID:
    2346
    Related biomarkers:
    Expression
    1d
    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)
    1d
    Synthesis and Preliminary Evaluation of the 211At-Labeled PARP Inhibitor [211At]Talazoparib as a Targeted Alpha-Particle Emitting Therapeutic. (PubMed, Mol Pharm)
    In recent years, derivatives of olaparib and rucaparib have been radiolabeled for noninvasive imaging of PARP1 expression and targeted radionuclide therapy of PARP-expressing tumors. Methods for the chiral separation of precursor permitted radiolabeling of [211At]talazoparib without the need for separation from its inactive 211At-labeled enantiomer after radiolabeling, and scaled-up production was optimized. [211At]talazoparib exhibited promising potential as a targeted radiotherapeutic, particularly for settings where locoregional administration is warranted.
    Journal • PARP Biomarker
    |
    PARP1 (Poly(ADP-Ribose) Polymerase 1)
    |
    FOLH1 positive
    |
    Lynparza (olaparib) • Talzenna (talazoparib) • Rubraca (rucaparib)
    5d
    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)
    11d
    A Study of TRC003 in the Treatment of Patients With Progressive PSMA-positive mCRPC (clinicaltrials.gov)
    P1/2, N=90, Recruiting, C Ray Therapeutics | Not yet recruiting --> Recruiting
    Enrollment open
    |
    FOLH1 positive
    12d
    AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01) (clinicaltrials.gov)
    P3, N=670, Recruiting, AstraZeneca
    New P3 trial
    |
    FOLH1 positive
    |
    enzalutamide • abiraterone acetate • Nubeqa (darolutamide) • cabazitaxel • apalutamide • Xofigo (radium Ra-223 dichloride) • AiRuiEn (rezvilutamide) • FPI-2265
    18d
    A Clinical Study Evaluating the Safety and Efficacy of Local Injection of ACT#001 Chimeric Antigen Receptor T Cells in the Treatment of Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=18, Enrolling by invitation, Zhejiang University | Not yet recruiting --> Enrolling by invitation | Initiation date: Dec 2025 --> Apr 2026
    Enrollment open • Trial initiation date
    |
    FOLH1 positive
    |
    cyclophosphamide • fludarabine IV
    18d
    PRESERVE-006: ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC (clinicaltrials.gov)
    P1/2, N=148, Active, not recruiting, OncoC4, Inc. | Trial completion date: Jun 2027 --> Nov 2027 | Trial primary completion date: Jun 2026 --> Nov 2026
    Trial completion date • Trial primary completion date
    |
    FOLH1 positive
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • gotistobart (BNT316)
    21d
    The predictive role of [177Lu]Lu-PSMA-617 SPECT/CT semiquantitative parameters from the 1st RLT cycle in advanced mCRPC: a preliminary bicentric lesion-based analysis. (PubMed, Eur J Nucl Med Mol Imaging)
    Our preliminary findings suggest that 1st cycle [¹⁷⁷Lu]Lu-PSMA-617 SPECT/CT semiquantitative parameters, especially when reflecting PSMA-expression, may serve as promising early predictors of the single-lesion response to RLT.
    Journal
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression • FOLH1 positive
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    22d
    Preclinical Evaluation of PSMA-Targeted Ultrasound Contrast Agents in an Orthotopic Model of Prostate Cancer in Rabbits. (PubMed, bioRxiv)
    Compared to Plain-NBs, PSMA-NBs also exhibited improved retention (MTT +21%; AUCwo) in the rim and peritumoral areas. This study demonstrates the capability of PSMA-NBs to characterize prostate cancer by molecular CEUS beyond what is possible with conventional MBs.
    Preclinical • Journal
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression • FOLH1 positive
    25d
    PROSPECTOR: Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer (clinicaltrials.gov)
    P1/2, N=152, Not yet recruiting, AstraZeneca
    New P1/2 trial
    |
    FOLH1 positive
    |
    docetaxel • AZD9574 • FPI-2265
    27d
    Percutaneous Thermo-ablation for the Treatment of Prostate Cancer Oligometastatasis (TA-P-OLIM) (clinicaltrials.gov)
    P=N/A, N=0, Withdrawn, University Hospital, Ghent | N=50 --> 0 | Initiation date: Jan 2026 --> May 2026 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial initiation date • Trial withdrawal
    |
    FOLH1 positive
    28d
    PSMA-directed nanoprobe enabling precision imaging and MR-guided chemoradiotherapy in prostate cancer. (PubMed, J Control Release)
    The GPNPs induced robust tumor growth inhibition in vivo with minimal systemic toxicity, while concurrently suppressing lung metastasis through enhanced CD8+ T-cell infiltration and increased effector cytokine production. These results highlight GPNPs as a potent and versatile nanoplatform for precision imaging of locally advanced PCa and enhanced MR-guided chemoradiotherapy.
    Journal
    |
    CD8 (cluster of differentiation 8)
    |
    FOLH1 positive