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    CANCER:

    Biliary Tract Cancer

    Related cancers:
    24h
    Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=330, Recruiting, I-Mab Biopharma US Limited | N=168 --> 330 | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
    Enrollment change • Trial completion date • Trial primary completion date
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    PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
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    Opdivo (nivolumab) • Imfinzi (durvalumab) • givastomig (TJ-CD4B)
    1d
    A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=151, Not yet recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd.
    New P2 trial
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    CLDN18 (Claudin 18)
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    CLDN18.2 positive
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    garetatug rezetecan (SHR-A1904)
    2d
    Target Therapies Resistance Molecular Profiling in Patients With Neoplastic Disease (clinicaltrials.gov)
    P=N/A, N=2500, Recruiting, Fondazione del Piemonte per l'Oncologia | Unknown status --> Recruiting | Trial completion date: Dec 2021 --> Mar 2026 | Trial primary completion date: Jun 2018 --> Mar 2026
    Enrollment open • Trial completion date • Trial primary completion date
    2d
    ARTEMIDE-Bil01: Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01) (clinicaltrials.gov)
    P3, N=757, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed
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    cisplatin • gemcitabine • capecitabine • Teysuno (gimeracil/oteracil/tegafur) • rilvegostomig (AZD2936)
    3d
    Beamion PANTUMOR-1: rationale and design of a Phase II trial of zongertinib in HER2-overexpressed/amplified or HER2-mutant solid tumors. (PubMed, Future Oncol)
    Secondary endpoints include duration of response, progression-free survival, disease control, occurrence of treatment-emergent adverse events, and health-related quality of life. Recruitment is ongoing in 13 countries globally.Clinical trial registration http://www.clinicaltrials.gov identifier is NCT06581432.
    P2 data • Journal • Pan tumor
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 mutation • EGFR wild-type • HER-2 positive + HER-2 overexpression
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    Hernexeos (zongertinib)
    3d
    AK117-202: A Study of AK112 in Advanced Malignant Tumors (clinicaltrials.gov)
    P1/2, N=154, Completed, Akeso | N=250 --> 154 | Trial completion date: Jun 2026 --> Dec 2025 | Trial primary completion date: May 2025 --> Nov 2025 | Active, not recruiting --> Completed
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    Yidafan (ivonescimab) • ligufalimab (AK117)
    3d
    A Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer (clinicaltrials.gov)
    P1/2, N=135, Recruiting, Akeso | Not yet recruiting --> Recruiting
    Enrollment open
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    Yidafan (ivonescimab)
    4d
    Fibroblast Growth Factor Receptor (FGFR) Inhibitors for the Treatment of Cholangiocarcinoma: Key Therapeutic Developments and Knowledge Gaps. (PubMed, Drug Des Devel Ther)
    Parallel translational work using cfDNA-based liquid biopsy has mapped a spectrum of secondary kinase-domain mutations that underlie acquired resistance, informing the development of next-generation FGFR2-selective inhibitors (eg, lirafugratinib) and combination strategies with EGFR/ERBB blockade. Collectively, these data underscore the need for comprehensive molecular profiling and innovative umbrella trial designs to optimise targeted therapy in this rare, biologically heterogeneous malignancy.
    Review • Journal • MSi-H Biomarker
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • FGFR (Fibroblast Growth Factor Receptor)
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    BRAF V600E • MSI-H/dMMR • HER-2 amplification • BRAF V600 • IDH1 mutation • FGFR2 mutation • FGFR2 fusion • IDH mutation + BRAF V600E
    |
    lirafugratinib (RLY-4008)
    7d
    Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) (clinicaltrials.gov)
    P3, N=810, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2025 --> May 2027
    Trial completion date
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine
    7d
    CROCOBIL: Testing Mitazalimab in Combination With Standard Chemotherapy in Immunotherapy Resistant Advanced Biliary Tract Cancers (clinicaltrials.gov)
    P2/3, N=160, Not yet recruiting, UNICANCER
    New P2/3 trial
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    5-fluorouracil • oxaliplatin • leucovorin calcium • mitazalimab (ADC-1013)
    7d
    A Post-marketing Observational Study of Tasfygo in Participants With Unresectable Biliary Tract Cancer With Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion Gene Positivity Who Progressed After Chemotherapy (clinicaltrials.gov)
    P=N/A, N=60, Recruiting, Eisai Co., Ltd. | Trial completion date: Nov 2030 --> Nov 2032 | Trial primary completion date: Nov 2030 --> Nov 2032
    Trial completion date • Trial primary completion date
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    FGFR2 (Fibroblast growth factor receptor 2)
    |
    FGFR2 fusion
    |
    Tasfygo (tasurgratinib)
    8d
    Mitochondrial targets in IDH1-mutated cholangiocarcinoma. (PubMed, Hepatol Commun)
    In this report, we discuss the emerging role of mitochondrial metabolism as a target in IDH1-mutated CCA, including preclinical evidence supporting the inhibition of the tricarboxylic acid (TCA) cycle, glutamine metabolism, and potential combination approaches. We aim to highlight the growing need to integrate mitochondrial-targeted strategies into future clinical investigations.
    Journal
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
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    Tibsovo (ivosidenib)