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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
    1m
    PROSPECTOR: Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer (clinicaltrials.gov)
    P1/2, N=152, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open
    |
    FOLH1 positive
    |
    docetaxel • AZD9574 • FPI-2265
    1m
    Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT (clinicaltrials.gov)
    P1, N=33, Active, not recruiting, Novartis Pharmaceuticals | Phase classification: P1/2 --> P1 | Trial completion date: Nov 2029 --> Mar 2031 | Trial primary completion date: Nov 2026 --> Mar 2031
    Phase classification • Trial completion date • Trial primary completion date
    |
    FOLH1 positive
    1m
    Evolving Systemic Therapy for Prostate Cancer: Pivotal Clinical Trials, Biomarker-Driven Combinations, and Practical Sequencing in the ARSI-PARP-Radioligand Era. (PubMed, Cancers (Basel))
    In mCSPC, androgen deprivation therapy plus docetaxel and/or androgen receptor signaling inhibitors (ARSIs) improves survival, with triplet regimens favored for selected chemotherapy-fit patients with aggressive de novo disease...Ongoing trials are evaluating earlier theranostics, alpha-emitting radioligands, and biomarker-enriched combinations. An implementation-first approach that intensifies treatment when appropriate, tests early and acts on HRR results, uses PSMA PET to guide RLT, and preserves hematologic reserve may maximize access to multiple life-prolonging mechanisms.
    Review • Journal • PARP Biomarker
    |
    HRD (Homologous Recombination Deficiency) • FOLH1 (Folate hydrolase 1) • PARP1 (Poly(ADP-Ribose) Polymerase 1)
    |
    FOLH1 expression • FOLH1 positive
    |
    docetaxel
    1m
    Imaging of Prostate Cancer Tumours Using 177Lu-NTA-476 (ACTRN12625001028493)
    P0, N=10, Recruiting, GenesisCare | Not yet recruiting --> Recruiting
    Enrollment open • Trial initiation date
    |
    FOLH1 positive
    2ms
    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)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    2ms
    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
    2ms
    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 • prednisolone
    3ms
    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
    3ms
    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)