^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG CLASS:

    HER2 inhibitor

    Related drugs:
    1d
    RESPECT-CMV: Renal Ex Vivo SYN002 Perfusion to Eliminate CMV Transmission (clinicaltrials.gov)
    P1, N=12, Not yet recruiting, University Health Network, Toronto
    New P1 trial
    4d
    CHANCES: A Phase 1 First-In-Human Study of the Anti-CD73 IPH5301 Alone or in Combination With Chemotherapy and Trastuzumab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=27, Recruiting, Institut Paoli-Calmettes | Trial completion date: Feb 2026 --> Mar 2027 | Trial primary completion date: Mar 2025 --> Mar 2027
    Trial completion date • Trial primary completion date • First-in-human
    |
    PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA (Breast cancer early onset)
    |
    PD-L1 expression • HER-2 positive • HER-2 amplification • HER-2 expression • BRCA mutation • PD-L1 expression + HER-2 overexpression
    |
    Herceptin (trastuzumab) • paclitaxel • IPH5301
    4d
    Study of Tucatinib and Doxil in Participants With Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=36, Recruiting, SCRI Development Innovations, LLC | Trial completion date: Jul 2026 --> Nov 2027 | Trial primary completion date: Jul 2026 --> Nov 2027
    Trial completion date • Trial primary completion date
    |
    Tukysa (tucatinib) • pegylated liposomal doxorubicin
    5d
    Tucatinib-trastuzumab-capecitabine for treatment of leptomeningeal metastasis in women with HER2+ breast cancer: TBCRC049 phase 2 study results. (PubMed, Nat Cancer)
    These data support systemic therapy as an approach in HER2+ breast cancer LM. ClinicalTrials.gov registration: NCT03501979 .
    Clinical • P2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR positive
    |
    Herceptin (trastuzumab) • capecitabine • Tukysa (tucatinib)
    7d
    DF1001-001: Study of DF1001 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=270, Completed, Dragonfly Therapeutics | Recruiting --> Completed | Trial completion date: Dec 2026 --> Dec 2025 | Trial primary completion date: Oct 2026 --> Dec 2025
    Trial completion • Trial completion date • Trial primary completion date • First-in-human
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 overexpression • HER-2 negative • HER-2 mutation • HER-2 positive + HER-2 overexpression
    |
    HercepTest
    |
    Opdivo (nivolumab) • albumin-bound paclitaxel • Trodelvy (sacituzumab govitecan-hziy) • DF1001
    7d
    Outcomes for Patients With Micro-Invasive or Small HER2+ Breast Cancer in Northern Sydney Local Health District. (PubMed, Asia Pac J Clin Oncol)
    Patients with microinvasive or small HER2+ node-negative breast cancer experience favorable outcomes. The pT1b group had higher histological grades and proliferative indices. Patients with pT1b disease or higher tumor grades were more likely to receive trastuzumab. While trastuzumab is recommended for pT1b disease with strong evidence, its use in pT1a disease should be balanced against its unclear benefits and known toxicities.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Herceptin (trastuzumab)
    7d
    Conversion surgery following trastuzumab and docetaxel combination therapy for unresectable HER2-positive parotid gland cancer. (PubMed, Auris Nasus Larynx)
    These cases suggest that systemic HER2-targeted therapy can serve as an effective neoadjuvant approach for locally advanced HER2-positive SGCs. Conversion surgery following Tmab and DTX treatment may offer a curative option in selected patients initially deemed inoperable.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 overexpression • HER-2 positive + HER-2 overexpression
    |
    Herceptin (trastuzumab) • docetaxel
    7d
    HER-OIC: Perioperative Zanidatamab and Chemotherapy for HER2 Positive Gastroesophageal Cancer (clinicaltrials.gov)
    P1/2, N=29, Not yet recruiting, Universitaire Ziekenhuizen KU Leuven
    New P1/2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Tevimbra (tislelizumab-jsgr) • Ziihera (zanidatamab-hrii)
    9d
    The Efficacy and Safety of Trastuzumab Rezetecan (SHR-A1811) in HER2-Low Unresectable/Metastatic Breast Cancer Patients With Visceral Crisis (clinicaltrials.gov)
    P2, N=184, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting --> Recruiting | Initiation date: Nov 2025 --> Mar 2026
    Enrollment open • Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Herceptin (trastuzumab) • gemcitabine • capecitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate) • vinorelbine tartrate • trastuzumab rezetecan (SHR-A1811)
    9d
    Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer. (clinicaltrials.gov)
    P1/2, N=40, Active, not recruiting, Criterium, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Aug 2024 --> Mar 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CD4 (CD4 Molecule)
    |
    HER-2 positive • PIK3CA mutation
    |
    Guardant360® CDx • FoundationOne® Liquid CDx • therascreen® PIK3CA RGQ PCR Kit
    |
    Piqray (alpelisib) • fulvestrant • Tukysa (tucatinib)
    9d
    Pyrotinib or placebo in combination with trastuzumab and docetaxel for HER2 positive metastatic breast cancer: long term survival results from randomised phase 3 PHILA trial. (PubMed, BMJ)
    The updated analysis of the phase 3 PHILA trial confirmed the superiority of pyrotinib in combination with trastuzumab and docetaxel over placebo in combination with trastuzumab and docetaxel in sustaining longer progression-free survival and improving overall survival for initial treatment of HER2 positive metastatic breast cancer. The safety profile remained consistent with interim findings, with no new safety signals identified during extended follow-up. This analysis reinforces the efficacy of this dual anti-HER2 (pyrotinib plus trastuzumab) regimen as an effective treatment strategy for this patient population.
    Clinical • P3 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • EGFR positive
    |
    Herceptin (trastuzumab) • docetaxel • Irene (pyrotinib)
    10d
    Copy Number-Based Oncogene Dominance May Suggest ERBB2 Dependence and Trastuzumab Response in HER2-Positive Gastric Cancer. (PubMed, Target Oncol)
    Copy number-based oncogene dominance may suggest tumor dependence and response to HER2-targeted therapy, highlighting a potential novel biomarker in HER2-positive gastric cancer.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • FGFR2 (Fibroblast growth factor receptor 2) • CCNE1 (Cyclin E1)
    |
    HER-2 positive • HER-2 amplification • EGFR positive
    |
    Herceptin (trastuzumab) • oxaliplatin • Teysuno (gimeracil/oteracil/tegafur)