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    DRUG:

    Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)

    i
    Other names: RG597 (SC formulation), trastuzumab SC, reformulated Herceptin
    Company:
    Halozyme, Roche
    Drug class:
    HER2 inhibitor
    Related drugs:
    29d
    A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants (clinicaltrials.gov)
    P1, N=312, Recruiting, Genentech, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    2ms
    A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants (clinicaltrials.gov)
    P1, N=312, Not yet recruiting, Genentech, Inc.
    New P1 trial
    |
    Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    2ms
    Thrombospondin-4 from Cancer-associated Fibroblasts Downregulates ERBB2 Expression in Gastric Cancer Cells. (PubMed, Carcinogenesis)
    The effects of Herceptin or gabapentin, a THBS4 receptor inhibitor, on subcutaneous tumors were examined in nude mice...In vivo, CAFs suppress HER2 expression of subcutaneous GC tumors and induce Herceptin resistance...THBS4 from CAFs downregulated HER2 (ERBB2) expression in GC cells. Thus, THBS4 receptor inhibitors may be useful in preventing the acquisition of resistance to anti-HER2 therapy.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • THBS4 (Thrombospondin 4)
    |
    HER-2 positive • HER-2 expression
    |
    Herceptin (trastuzumab) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    2ms
    Chimeric Receptor T Cells With Trastuzumab in HER2+ Advanced Breast Cancer and Other Solid Tumors (clinicaltrials.gov)
    P1/2, N=36, Not yet recruiting, National University Hospital, Singapore | Phase classification: P2 --> P1/2 | Trial primary completion date: Dec 2025 --> Dec 2026
    Phase classification • Trial primary completion date
    |
    HER-2 positive • HER-2 amplification
    |
    Herceptin (trastuzumab) • cyclophosphamide • fludarabine IV • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    4ms
    A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=76, Recruiting, Daiichi Sankyo | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    5ms
    To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab) (clinicaltrials.gov)
    P1, N=200, Active, not recruiting, Celltrion | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Herzuma (trastuzumab-pkrb) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    5ms
    Optimizing neoadjuvant treatment in HER2-positive breast cancer: the role of HER2, HR, PD-L1 expression and regimen selection. (PubMed, Future Oncol)
    The intravenous formulation (Herceptin) or subcutaneous formulation (Herceptin Hylecta) of the original trastuzumab drug, as well as the biosimilar drugs (Hanquyou) produced in China, showed similar efficacy, while Nab-Paclitaxel demonstrated potential benefits in overall patient. HER2 3+, PD-L1 CPS > 27.5 and HR-negative are independent predictors of pCR. The TCbHP and THP regimens have comparable efficacy, and both are superior to the AC-THP regimen.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • HER-2 positive • HER-2 expression
    |
    albumin-bound paclitaxel • Hercessi (trastuzumab-strf) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    6ms
    A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=76, Not yet recruiting, Daiichi Sankyo
    New P1 trial
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    6ms
    ATEMPT 2.0: Adjuvant T-DM1 vs TH (clinicaltrials.gov)
    P2, N=500, Recruiting, Dana-Farber Cancer Institute | Trial primary completion date: May 2025 --> Nov 2026
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative
    |
    Herceptin (trastuzumab) • paclitaxel • Kadcyla (ado-trastuzumab emtansine) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    7ms
    To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab) (clinicaltrials.gov)
    P1, N=200, Recruiting, Celltrion | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Herzuma (trastuzumab-pkrb) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    10ms
    A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001) (clinicaltrials.gov)
    P2, N=66, Active, not recruiting, Pfizer | Trial completion date: Dec 2028 --> Nov 2025
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    capecitabine • Tukysa (tucatinib) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    10ms
    CUPISCO: A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site (clinicaltrials.gov)
    P2, N=528, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Nov 2024
    Trial completion • Trial completion date
    |
    Avastin (bevacizumab) • Lynparza (olaparib) • cisplatin • Tecentriq (atezolizumab) • erlotinib • Zelboraf (vemurafenib) • carboplatin • gemcitabine • Rozlytrek (entrectinib) • paclitaxel • Alecensa (alectinib) • Perjeta (pertuzumab) • Cotellic (cobimetinib) • Pemazyre (pemigatinib) • Tibsovo (ivosidenib) • ipatasertib (RG7440) • Erivedge (vismodegib) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)