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    CANCER:

    Biliary Tract Cancer

    Related cancers:
    16h
    Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors (clinicaltrials.gov)
    P1, N=160, Recruiting, SystImmune Inc. | N=120 --> 160
    Enrollment change
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • CLDN18 (Claudin 18) • NTRK (Neurotrophic receptor tyrosine kinase)
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    PD-L1 expression • KRAS mutation • MSI-H/dMMR • HER-2 overexpression • BRAF mutation • HER-2 mutation • IDH1 mutation • CLDN18.2 expression • FGFR2 mutation • FGFR2 fusion • IDH mutation + NTRK fusion • NTRK fusion
    1d
    Spatial immune profiling complements genomic sequencing in biliary tract cancer: hypothesis-generating use cases. (PubMed, ESMO Gastrointest Oncol)
    In contrast, a patient with loss of BAP1 was linked to a CD8+ T-cell enriched tumor microenvironment, classified as spatially immune enriched and responded long-term to subsequent immune checkpoint inhibition and tyrosine kinase inhibition therapy. These observations provide a rationale for integrated genomic and spatial immune profiling in BTC, which will require further prospective validation.
    Journal • BRCA Biomarker • IO biomarker
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    BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • CD8 (cluster of differentiation 8) • BAP1 (BRCA1 Associated Protein 1)
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    BRCA2 mutation • HRD
    4d
    PMEPA1 modulates YAP1 nuclear translocation to disrupt EMT subtypes and promote metastasis in Biliary tract cancer. (PubMed, Cell Death Dis)
    This liberates YAP1 to translocate into the nucleus and initiate a pro-EMT gene expression program. Finally, we demonstrate that the drug candidate SN-38 suppresses metastasis by interfering with this PMEPA1/YAP1 signaling module.
    Journal
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    YAP1 (Yes associated protein 1) • ITK (IL2 Inducible T Cell Kinase) • LATS1 (Large Tumor Suppressor Kinase 1)
    4d
    Emavusertib (CA-4948) in Combination With Cisplatin, Gemcitabine, and Durvalumab in Patients With Untreated Advanced or Metastatic Biliary Tract Cancer (clinicaltrials.gov)
    P1, N=48, Recruiting, Washington University School of Medicine | Not yet recruiting --> Recruiting
    Enrollment open
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    cisplatin • Imfinzi (durvalumab) • gemcitabine • emavusertib (CA-4948)
    5d
    EAY191-A6: Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial) (clinicaltrials.gov)
    P2, N=66, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: May 2026 --> Oct 2026 | Trial primary completion date: May 2026 --> Oct 2026
    Trial completion date • Trial primary completion date
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    MAPK1 (Mitogen-activated protein kinase 1)
    |
    BRAF V600E • BRAF V600
    |
    Mektovi (binimetinib) • oxaliplatin • leucovorin calcium • fluorouracil topical
    5d
    ZM008-001: This is a Phase 1 Trial of ZM008, an Anti-LLT1 Antibody, Used as Single Agent Followed by Combination Treatment With Toripalimab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=100, Recruiting, Zumutor Biologics Inc. | N=33 --> 100
    Enrollment change
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    Loqtorzi (toripalimab-tpzi) • ZM008
    6d
    SHIELD: Trastuzumab in Combination With Serplulimab and Chemotherapy for the Treatment of HER2-overexpressing Unresectable Locally Advanced or Metastatic Biliary Tract Cancer or Urothelial Carcinoma After Failure of Standard Therapy (clinicaltrials.gov)
    P2, N=20, Recruiting, Xiujuan Qu
    New P2 trial
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 overexpression
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    Herceptin (trastuzumab) • oxaliplatin • Hetronifly (serplulimab)
    7d
    Global patterns of mutational profiles in biliary tract cancer. (PubMed, J Hepatol)
    This cross-study integrative analysis provides an international view of BTC genomics, codifying how geography, etiology, and anatomical subtype together shape driver landscapes.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • BAP1 (BRCA1 Associated Protein 1)
    7d
    A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=151, Recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CLDN18 (Claudin 18)
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    CLDN18.2 positive
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    garetatug rezetecan (SHR-A1904)
    8d
    Assessment of Safety, Tolerability and Pharmacokinetics With BAT8010 for Injection in Advanced Malignant Solid Tumors Patients (clinicaltrials.gov)
    P1, N=23, Completed, Bio-Thera Solutions | Recruiting --> Completed | N=109 --> 23
    Trial completion • Enrollment change
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
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    BAT8010
    8d
    Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers (clinicaltrials.gov)
    P1/2, N=31, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2027 --> Dec 2029 | Trial primary completion date: Dec 2026 --> Dec 2028
    Trial completion date • Trial primary completion date
    |
    Fotivda (tivozanib)
    9d
    AB02: A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02) (clinicaltrials.gov)
    P3, N=186, Recruiting, AstraZeneca | N=89 --> 186
    Enrollment change
    |
    PD-L1 (Programmed death ligand 1)
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • rilvegostomig (AZD2936)