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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:
Related biomarkers:
3d
Trial completion
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FOLH1 positive
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Nubeqa (darolutamide)
5d
Redefining standards: a comprehensive systematic review of practice changing advances in GU oncology from ASCO and ESMO 2025. (PubMed, Front Endocrinol (Lausanne))
Key advances include: (1) In bladder cancer, perioperative durvalumab (NIAGARA) and enfortumab vedotin plus pembrolizumab (KEYNOTE-905/EV-303) set new standards, while HER2-targeted disitamab vedotin plus toripalimab (RC48-C016) improved metastatic survival...(3) In prostate cancer, enzalutamide plus leuprolide improved survival in high-risk biochemical recurrence (EMBARK). Capivasertib plus abiraterone benefited PTEN-deficient metastatic hormone-sensitive disease (CAPItello-281). The PSMAddition trial demonstrated that adding [177Lu]Lu-PSMA-617 to standard therapy significantly improved radiographic PFS in PSMA-positive mHSPC. Docetaxel scheduling was optimized (ARASAFE), and an AI model (STAMPEDE) identified patients for AR inhibitor benefit. Novel agents like saruparib and pasritamig showed promise...The 2025 evidence establishes multiple new standards of care across GU cancers, emphasizing biomarker-driven strategies, immunotherapy integration, novel resistance mechanisms, and treatment optimization. This synthesis provides an evidence-based framework for updating guidelines and highlights the move toward more personalized management, while noting persistent challenges and future research needs.
Review • Journal • PD(L)-1 Biomarker • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • PTEN (Phosphatase and tensin homolog)
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FOLH1 positive
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Keytruda (pembrolizumab) • Imfinzi (durvalumab) • docetaxel • Loqtorzi (toripalimab-tpzi) • Xtandi (enzalutamide) • abiraterone acetate • Truqap (capivasertib) • Aidixi (disitamab vedotin) • Padcev (enfortumab vedotin-ejfv) • saruparib (AZD5305) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • leuprolide acetate for depot suspension • pasritamig (JNJ-8343)
5d
Circulating tumor cell detection in cancer patients using in-flow deep learning holography. (PubMed, NPJ Biosens)
Notably, nearly two-thirds of identified CTCs were EpCAM-negative but PSMA positive (a prostate specific epithelial marker), suggesting that traditional use of EpCAM as an epithelial marker for CTCs may lead to false negatives. These findings highlight the potential of DHM for applications including but not limited to screening, diagnostics, and precision oncology.
Journal • Circulating tumor cells
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EPCAM (Epithelial cell adhesion molecule)
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FOLH1 positive
6d
177Lu-PSMA-617 in Metastatic Castration Resistant Prostate Cancer (mCRPC) With Bone Marrow Involvement and Cytopenia (clinicaltrials.gov)
P2, N=40, Suspended, M.D. Anderson Cancer Center | Initiation date: Dec 2025 --> Aug 2025 | Recruiting --> Suspended
Trial initiation date • Trial suspension
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FOLH1 positive
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
7d
Study of TRDC002 in the Diagnosis of Patients With PSMA-positive Prostate Cancer (clinicaltrials.gov)
P1, N=6, Active, not recruiting, C Ray Therapeutics | Recruiting --> Active, not recruiting
Enrollment closed
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FOLH1 positive
13d
Testing the Safety of the Anti-cancer Drug, Sn-117m-DTPA, for Advanced Cancers That Have Spread to Bones (clinicaltrials.gov)
P1, N=24, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Mar 2026 --> Oct 2026
Trial initiation date • First-in-human
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ER (Estrogen receptor) • PGR (Progesterone receptor)
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HER-2 positive • HR positive • FOLH1 positive
14d
AlphaBreak: FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
P2, N=110, Active, not recruiting, Fusion Pharmaceuticals Inc. | Trial primary completion date: Jul 2026 --> Dec 2026 | Recruiting --> Active, not recruiting
Enrollment closed • Trial primary completion date
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BRCA (Breast cancer early onset)
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BRCA mutation • FOLH1 positive
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FPI-2265
22d
PAnTHA: First-in-human Study of 225Ac-PSMA-Trillium (BAY 3563254) in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
P1, N=198, Recruiting, Bayer | N=73 --> 198 | Trial completion date: May 2031 --> May 2032 | Trial primary completion date: Jun 2027 --> Nov 2028
Enrollment change • Trial completion date • Trial primary completion date • First-in-human
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FOLH1 positive
26d
Prostate-Specific Membrane Antigen (PSMA): A Potential Theranostic Biomarker in Breast Cancer. (PubMed, Biomedicines)
Our results suggest that PSMA could be used as a biomarker in BC, given that it is highly expressed in more aggressive tumors. These findings open the way to a clinical investigation for the possible use of PSMA as a theranostic biomarker in BC patients with PSMA positive PET scan.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 expression • FOLH1 positive
1m
New trial
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FOLH1 positive
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
1m
Comparative evaluation of [¹⁸F]FAPI-42 and [¹⁸F]PSMA-1007 PET/CT for lesion detection and uptake in prostate cancer across disease stages. (PubMed, EJNMMI Res)
While [¹⁸F]PSMA 1007 PET/CT remains superior for overall lesion detection, [¹⁸F]FAPI 42 PET/CT may provide complementary value in selected scenarios, particularly in subsets with reduced PSMA expression.
Journal
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FOLH1 (Folate hydrolase 1) • FAP (Fibroblast activation protein, alpha)
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FOLH1 expression • FOLH1 positive
1m
Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC (clinicaltrials.gov)
P2, N=12, Recruiting, H. Lee Moffitt Cancer Center and Research Institute
New P2 trial
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FOLH1 positive