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    CELLSEARCH®

    Company:
    Menarini
    Type:
    FDA Cleared (510k)
    7d
    ECOG-ACRIN 5103: Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer (clinicaltrials.gov)
    P3, N=4994, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Feb 2026 --> Feb 2027
    Trial completion date
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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    CELLSEARCH®
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    Avastin (bevacizumab) • paclitaxel • doxorubicin hydrochloride • cyclophosphamide • Aybintio (bevacizumab biosimilar) • Vegzelma (bevacizumab-adcd) • Avzivi (bevacizumab-tnjn)
    12d
    PD-L1-positive circulating tumor cells associate with tumor malignancy and impaired circulating immunity in patients with gastrointestinal tumors. (PubMed, Sci Rep)
    These findings indicate that PD-L1+CTCs reflect tumor-driven immune suppression and may facilitate metastatic spread. Therefore, PD-L1+CTCs should be considered as promising prognostic biomarkers and may provide a rationale for early immunotherapy.
    Journal • Circulating tumor cells • PD(L)-1 Biomarker • IO biomarker
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    PD-L1 (Programmed death ligand 1)
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    PD-L1 expression
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    CELLSEARCH®
    12d
    Analytical approaches for the isolation and characterisation of circulating tumour cells in clinical practice. (PubMed, Clin Chim Acta)
    Integration with other circulating biomarkers, such as circulating tumour DNA and exosomes, promise enhanced prognostic and diagnostic accuracy. Standardization of protocols and validation in clinical samples will be critical for translating these technologies into routine oncology practice.
    Review • Journal • Circulating tumor cells
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    CELLSEARCH®
    20d
    Temozolomide With or Without Veliparib in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=97, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2026 --> Mar 2027
    Trial completion date
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    CELLSEARCH®
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    temozolomide • veliparib (ABT-888)
    28d
    Phase I/II Trial of Pembrolizumab and Androgen-receptor Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1/2, N=52, Recruiting, Weill Medical College of Cornell University | Active, not recruiting --> Recruiting | N=37 --> 52
    Enrollment open • Enrollment change
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    CELLSEARCH®
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    Keytruda (pembrolizumab) • enzalutamide • Ac-225 rosopatamab tetraxetan (CONV01-α)
    29d
    Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC (clinicaltrials.gov)
    P1, N=16, Completed, Weill Medical College of Cornell University | Active, not recruiting --> Completed | Trial completion date: Oct 2026 --> Oct 2025
    Trial completion • Trial completion date
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    CELLSEARCH®
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    docetaxel • abiraterone acetate • prednisone • apalutamide
    1m
    Translating Liquid Biopsy into Practice- The Promise and Challenges of Circulating Tumor Cells in Ovarian and Lung Cancer Management. (PubMed, Biomark Insights)
    CTCs represent a powerful liquid biopsy tool with potential to revolutionize cancer diagnostics and precision medicine. Integration of multi-omics profiling, CTC-derived organoids, and AI-driven analytical models may further enhance their clinical utility in guiding personalized treatment strategies for ovarian and lung cancer patients.
    Review • Journal • Circulating tumor cells • Liquid biopsy
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    CELLSEARCH®
    2ms
    Cytoplasmic versus nuclear localization of androgen receptor splice variant 7 as a predictor of benefit from androgen receptor pathway inhibitors in metastatic castration-resistant prostate cancer (PROPHECY trial). (PubMed, Prostate Cancer Prostatic Dis)
    This study clarifies the clinical relevance of cytoplasmic AR-V7 in circulating tumor cells from men with metastatic castration-resistant prostate cancer. While nuclear-localized AR-V7 predicts extremely poor response, PFS, and overall survival with AR pathway inhibitors, cytoplasmic AR-V7 expands the definition of AR-V7-positive status and identifies patients with equally poor PFS and intermediate response and overall survival outcomes. Assessing both nuclear and cytoplasmic AR-V7 fractions may thus improve risk stratification heterogeneity and could better guide poor-risk ARPI treatment decisions by avoiding ineffective ARPI treatment, helping personalize therapy, and improving outcomes in men with mCRPC.
    Journal
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    AR (Androgen receptor)
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    AR splice variant 7
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    CELLSEARCH®
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    enzalutamide • abiraterone acetate
    2ms
    Phase I Study of 225Ac-J591 Plus 177Lu-PSMA Small Molecule for Progressive Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=20, Active, not recruiting, Weill Medical College of Cornell University | Suspended --> Active, not recruiting | Phase classification: P1/2 --> P1 | N=48 --> 20 | Trial completion date: Dec 2027 --> Dec 2029 | Trial primary completion date: Dec 2026 --> Dec 2027
    Enrollment closed • Phase classification • Enrollment change • Trial completion date • Trial primary completion date
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    CELLSEARCH®
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    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Ac-225 rosopatamab tetraxetan (CONV01-α)
    2ms
    LiB-PNS: Liquid Biopsy in Paraneoplastic Neurological Syndromes (clinicaltrials.gov)
    P=N/A, N=60, Recruiting, Heinrich-Heine University, Duesseldorf
    New trial • Liquid biopsy
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    CELLSEARCH®
    2ms
    CTC-EXPRESS: A Study for CTC Expression and cfDNA/RNA Assessment in Metastatic Breast Cancer Patients (clinicaltrials.gov)
    P=N/A, N=187, Recruiting, Menarini Silicon Biosystems, INC | Not yet recruiting --> Recruiting | Trial completion date: Mar 2029 --> Oct 2028 | Trial primary completion date: Oct 2027 --> Oct 2028
    Enrollment open • Trial completion date • Trial primary completion date • IO biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
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    HER-2 negative
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    CELLSEARCH®
    2ms
    LUCID: Insights on Dissemination of Lung Cancer (clinicaltrials.gov)
    P=N/A, N=100, Recruiting, IRCCS Azienda Ospedaliero-Universitaria di Bologna
    New trial
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    CELLSEARCH®