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    BIOMARKER:

    HER-2 positive

    i
    Other names: ERBB2, CD340, HER-2, HER2, NEU, NGL, V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2
    Entrez ID:
    2064
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    Related tests:
    1d
    TUXEDO-3: HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease (clinicaltrials.gov)
    P2, N=63, Active, not recruiting, MedSIR | Completed --> Active, not recruiting
    Enrollment closed
    |
    HER-2 positive • EGFR mutation • EGFR T790M
    |
    patritumab deruxtecan (U3-1402)
    1d
    HERIZON-BTC-302: Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer (clinicaltrials.gov)
    P3, N=286, Recruiting, Jazz Pharmaceuticals | Active, not recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Keytruda (pembrolizumab) • cisplatin • Imfinzi (durvalumab) • gemcitabine • Ziihera (zanidatamab-hrii)
    1d
    A Proximity-Driven, Spatially Matched 3D Aptasensor for Precise HER2 Diagnostics in Living Cells and Clinical Specimens. (PubMed, Anal Chem)
    The aptasensor effectively distinguished HER2-positive cancer cells and accurately quantified HER2 expression in clinical breast cancer tissues, particularly resolving diagnostically challenging IHC-equivocal (2+) cases with high consistency with FISH. By providing reliable HER2 assessments while reducing dependence on costly and time-consuming FISH, this platform offers a streamlined, accurate diagnostic tool to support personalized treatment decisions in breast cancer.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    1d
    BREAKER-101: Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=392, Recruiting, TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) | N=91 --> 392
    Enrollment change • First-in-human
    |
    KRAS (KRAS proto-oncogene GTPase) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 positive • HR positive • HER-2 negative • PIK3CA mutation • HR positive + HER-2 negative
    |
    Avastin (bevacizumab) • Herceptin (trastuzumab) • 5-fluorouracil • Kisqali (ribociclib) • fulvestrant • leucovorin calcium
    1d
    A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=76, Recruiting, Daiichi Sankyo | N=25 --> 76
    Enrollment change • Trial initiation date
    |
    HER-2 positive • HER-2 mutation
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    1d
    UCCL-IKF-AIO-STO-0124 NeoART-an international phase Ib/II platform trial investigating trastuzumab deruxtecan (T-DXd) combined with neoadjuvant chemotherapy for HER2-positive, resectable esophagogastric adenocarcinoma (EGA). (PubMed, ESMO Gastrointest Oncol)
    Recently, perioperative durvalumab in combination with chemotherapy (ctx) has shown improved event-free survival in biomarker-unselected patients with resectable EGA. UCCL-IKF-NeoART is an international, open-label, non-randomized phase Ib/II platform trial evaluating T-DXd in sequential cohorts, each combining the drug with a different ctx regimen. Every cohort includes an initial safety run-in phase.
    P1/2 data • Journal • PD(L)-1 Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Imfinzi (durvalumab) • Enhertu (fam-trastuzumab deruxtecan-nxki)
    1d
    Case Report: Sustained complete response achieved in a patient with advanced HER-2 positive gastric cancer after 4 years of chemotherapy-free treatment. (PubMed, Front Oncol)
    The patient was enrolled in a clinical study and received a combination of KN026 and KN046 targeted therapy with immunotherapy...The combination of anti-HER-2 bispecific targeting therapy and PD-1/CTLA-4 bispecific immunotherapy demonstrated promising efficacy and a favorable safety profile in this patient with advanced HER2-positive gastric cancer, achieving durable complete response without chemotherapy. This case provides a rationale for further exploring chemotherapy-free strategies using dual bispecific antibodies in carefully selected patients.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    anbenitamab (KN026)
    1d
    C-type lectin domain family 5 member A-mediated activation of macrophages via a bispecific antibody enhances anti-HER2 therapy. (PubMed, J Immunother Cancer)
    These results identify the CLEC5A-HER2 bispecific antibody as a potential immunotherapy for HER2-positive cancers by effectively engaging both innate and adaptive immunity.
    Journal
    |
    CD8 (cluster of differentiation 8) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • CXCR3 (C-X-C Motif Chemokine Receptor 3) • CLEC5A (C-Type Lectin Domain Containing 5A)
    |
    HER-2 positive
    1d
    Tumor Microenvironment-Responsive Antibody Fragment-Cleavable PEGylated Drug Conjugates (AFCDC) for Improved Tumor Penetration and Antitumor Efficacy. (PubMed, J Med Chem)
    Under the evaluated regimen, AFCDC demonstrated enhanced activity over T-DXd in the NCI-N87 xenografts. Overall, AFCDC resolves the antibody fragment trade-off, providing a strategy compatible with multiple formats and payloads to enhance the ADC efficacy in solid tumors.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • MMP2 (Matrix metallopeptidase 2)
    |
    HER-2 positive
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)