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    DRUG CLASS:

    BTLA inhibitor

    Related drugs:
    2d
    A Phase I Clinical Study of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=31, Terminated, Shanghai Junshi Bioscience Co., Ltd. | N=198 --> 31 | Recruiting --> Terminated; The trial was stopped early on the initiative of the sponsor on the basis of a change in the research and development strategy without safety concerns
    Enrollment change • Trial termination
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    Loqtorzi (toripalimab-tpzi) • tifcemalimab (TAB004)
    3d
    JS004 Combined With Toripalimab and With Standard Chemotherapy Treat Patients With Advanced Lung Cancer (clinicaltrials.gov)
    P1/2, N=119, Completed, Shanghai Junshi Bioscience Co., Ltd. | Active, not recruiting --> Completed
    Trial completion
    |
    cisplatin • carboplatin • paclitaxel • docetaxel • Loqtorzi (toripalimab-tpzi) • pemetrexed • etoposide IV • tifcemalimab (TAB004)
    14d
    HFB-200603-01: A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=83, Active, not recruiting, HiFiBiO Therapeutics | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600
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    Tevimbra (tislelizumab-jsgr) • HFB200603
    24d
    Review of design strategies for active targeted drug delivery systems for pancreatic cancer. (PubMed, Eur J Pharm Biopharm)
    The text introduces current pancreatic cancer treatment drugs, including gemcitabine, tegafur, and albumin-bound paclitaxel. The review offers a concise overview of the antibodies and ligands employed in active targeted drug delivery systems for PC, including hRS7, αTROP2, MF-T, TAB004, HzMUC1, as well as ligands such as EGF, GE11 peptide, Tf, tTR14, XQ-2d, cNGQ, α5β1-targeted peptide, IGF1, and SDC1. The therapeutic effects and prospects of combining active targeting strategies with photothermal therapy, immunotherapy, and gene editing technology are discussed in this paper.
    Review • Journal
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    EGFR (Epidermal growth factor receptor) • MSLN (Mesothelin) • GPC1 (Glypican 1) • IGF1 (Insulin-like growth factor 1) • SDC1 (Syndecan 1) • CA 19-9 (Cancer antigen 19-9)
    |
    gemcitabine • albumin-bound paclitaxel • tifcemalimab (TAB004)
    1m
    A Randomized Study of JS004 and Toripalimab Combined With Chemotherapy vs Toripalimab Combined With Chemotherapy vs Chemotherapy Alone as Neoadjuvant Therapy for Stage II-III Triple-negative Breast Cancer (TNBC) (ChiCTR2500108554)
    P2, N=125, Not yet recruiting, Shengjing Hospital of China Medical University; Shengjing Hospital of China Medical University
    New P2 trial
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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    HER-2 negative • HR negative • ER negative • HER-2 negative + HR negative
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    Loqtorzi (toripalimab-tpzi) • tifcemalimab (TAB004)
    2ms
    A Prospective，Single Arm, Multicenter Clinical Study of BTLA Monoclonal Antibody JS004 (B/T Lymphocyte Attenuator Factor Monoclonal Antibody) in Combination With Toripalimab in Patients With Unresectable or Advanced Renal Cell Carcinoma Who Had Failed Previous Immunotherapy (clinicaltrials.gov)
    P2, N=31, Not yet recruiting, RenJi Hospital | Trial completion date: Dec 2026 --> Dec 2027 | Initiation date: Dec 2024 --> Oct 2025 | Trial primary completion date: Mar 2026 --> Oct 2026
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    Loqtorzi (toripalimab-tpzi) • tifcemalimab (TAB004)
    4ms
    A Randomized Study of JS004 and Toripalimab Combined With Chemotherapy vs Toripalimab Combined With Chemotherapy vs Chemotherapy Alone as Neoadjuvant Therapy for Stage II-III Triple-negative Breast Cancer (TNBC). (clinicaltrials.gov)
    P2, N=125, Not yet recruiting, Shengjing Hospital
    New P2 trial
    |
    carboplatin • paclitaxel • Loqtorzi (toripalimab-tpzi) • doxorubicin hydrochloride • cyclophosphamide • epirubicin • tifcemalimab (TAB004)
    6ms
    Safety, Tolerability and Pharmacokinetics of a Recombinant Humanized mAb Specific to B-and T-Lymphocyte Attenuator (BTLA) for Injection in Subjects With Advanced Malignancies (clinicaltrials.gov)
    P1, N=47, Completed, Shanghai Junshi Bioscience Co., Ltd. | Recruiting --> Completed | N=200 --> 47
    Trial completion • Enrollment change
    |
    tifcemalimab (TAB004)
    7ms
    Tifcemalimab as monotherapy or in combination with toripalimab in patients with relapsed/refractory lymphoma: a Phase I trial. (PubMed, Nat Commun)
    Grade 3/4 treatment-related adverse events occurred in 3 patients (12·0%) in Part A and 15 patients (32·6%) in Part B. No fatal adverse events were observed. Tifcemalimab with or without toripalimab demonstrated a favorable safety profile in lymphoma patients.
    P1 data • Journal
    |
    BTLA (B And T Lymphocyte Associated)
    |
    Loqtorzi (toripalimab-tpzi) • tifcemalimab (TAB004)
    7ms
    Phase I/II Study of Tifcemalimab, an Anti-B and T-lymphocyte Attenuator Antibody, in Combination with Toripalimab in Previously Treated Advanced Lung Cancer. (PubMed, Clin Cancer Res)
    Tifcemalimab plus toripalimab showed promising antitumor activities with acceptable safety, especially, in advanced refractory SCLC.
    P1/2 data • Journal
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • BTLA (B And T Lymphocyte Associated)
    |
    ALK fusion
    |
    Loqtorzi (toripalimab-tpzi) • tifcemalimab (TAB004)
    8ms
    JS004 Combined With Toripalimab and With Standard Chemotherapy Treat Patients With Advanced Lung Cancer (clinicaltrials.gov)
    P1/2, N=119, Active, not recruiting, Shanghai Junshi Bioscience Co., Ltd. | Recruiting --> Active, not recruiting | N=240 --> 119 | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    cisplatin • carboplatin • paclitaxel • docetaxel • Loqtorzi (toripalimab-tpzi) • pemetrexed • etoposide IV • tifcemalimab (TAB004)
    10ms
    Study of JS004 Combined With Toripalimab for Advanced Lung Cancer (clinicaltrials.gov)
    P1/2, N=67, Completed, Shanghai Junshi Bioscience Co., Ltd. | Recruiting --> Completed | Trial primary completion date: Aug 2023 --> Oct 2024
    Trial completion • Trial primary completion date
    |
    Loqtorzi (toripalimab-tpzi) • tifcemalimab (TAB004)