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    DRUG:

    Ziihera (zanidatamab-hrii)

    i
    Other names: ZW25, ZW 25, ZW-25, JZP-598, JZP 598, JZP598
    Company:
    BeOne Medicines, Jazz, Zymeworks
    Drug class:
    HER2 inhibitor
    Related drugs:
    11d
    ZANGEA: Zanidatamab in Combination With Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients (clinicaltrials.gov)
    P2, N=80, Recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Not yet recruiting --> Recruiting | Initiation date: Oct 2025 --> Jan 2026
    Enrollment open • Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • HER-2 positive
    |
    Keytruda (pembrolizumab) • 5-fluorouracil • oxaliplatin • Ziihera (zanidatamab-hrii)
    28d
    A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC) (clinicaltrials.gov)
    P2, N=20, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2028 | Trial primary completion date: Dec 2025 --> Dec 2028
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    tamoxifen • letrozole • Ziihera (zanidatamab-hrii)
    28d
    HARBOR: Neoadjuvant Zanidatamab + Tislelizumab + Chemotherapy for Selective Bladder Preservation in HER2-Positive MIBC (clinicaltrials.gov)
    P2, N=25, Recruiting, Fujian Medical University Union Hospital
    New P2 trial
    |
    cisplatin • gemcitabine • Tevimbra (tislelizumab-jsgr) • albumin-bound paclitaxel • Ziihera (zanidatamab-hrii)
    30d
    AcSé HER2: Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene. (clinicaltrials.gov)
    P2, N=105, Recruiting, UNICANCER | Active, not recruiting --> Recruiting
    Enrollment open
    |
    Ziihera (zanidatamab-hrii)
    1m
    Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread (clinicaltrials.gov)
    P1/2, N=768, Recruiting, Boehringer Ingelheim | N=582 --> 768 | Trial completion date: Sep 2029 --> Jan 2029 | Trial primary completion date: Sep 2029 --> Jan 2029
    Enrollment change • Trial completion date • Trial primary completion date
    |
    5-fluorouracil • Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • oxaliplatin • leucovorin calcium • Ziihera (zanidatamab-hrii) • Hernexeos (zongertinib)
    1m
    HERIZON-GEA-01: A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers (clinicaltrials.gov)
    P3, N=920, Active, not recruiting, Jazz Pharmaceuticals | Trial completion date: May 2026 --> Jul 2027 | Trial primary completion date: Dec 2025 --> Jul 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    Herceptin (trastuzumab) • cisplatin • 5-fluorouracil • Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • Ziihera (zanidatamab-hrii)
    1m
    Zanidatamab Combined With Chemotherapy as Neoadjuvant Therapy for HER2-high Expression G/GEJC (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Xijing Hospital
    New P2 trial
    |
    Ziihera (zanidatamab-hrii)
    2ms
    Phase 1b/2 Study of Zanidatamab in Combination with Tislelizumab and Chemotherapy in First-Line HER2-Positive Gastric/Gastroesophageal Junction Adenocarcinoma. (PubMed, Clin Cancer Res)
    Zanidatamab, in combination with tislelizumab and CAPOX, demonstrated clinically meaningful antitumor activity with a manageable safety profile as first-line therapy for patients with HER2+ GC/GEJC. These results support further development of zanidatamab and tislelizumab with chemotherapy in this patient population in the ongoing phase 3 HERIZON-GEA-01 trial (NCT05152147).
    P1/2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • Ziihera (zanidatamab-hrii)
    2ms
    AcSé HER2: Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene. (clinicaltrials.gov)
    P2, N=105, Active, not recruiting, UNICANCER | Not yet recruiting --> Active, not recruiting
    Enrollment closed
    |
    Ziihera (zanidatamab-hrii)
    2ms
    Zanidatamab in combination with docetaxel in first-line HER2-positive breast cancer: results from an open-label, multicenter, phase Ib/II study. (PubMed, ESMO Open)
    Zanidatamab demonstrated efficacy and a manageable and tolerable safety profile with docetaxel as first-line treatment in patients with HER2-positive breast cancer. These data support the further development of zanidatamab in this patient population.
    P1/2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • EGFR positive
    |
    docetaxel • Ziihera (zanidatamab-hrii)