A Phase 2 Basket Study of Tucatinib in Combination With Trastuzumab in Subjects With Previously Treated Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Cervical Cancer & Uterine Cancer
  • Age: Between 18 years - 100 years
  • Gender: Female
  • Other Inclusion Criteria:
    1) Histologically or cytologically confirmed diagnosis of locally-advanced unresectable or metastatic solid tumor, including ovarian, endoemetrial and cervical. 2) Disease demonstrating HER2 alterations (overexpression/amplification or HER2 activating mutations), as determined by local or central testing processed in a Clinical Laboratory Improvement Amendments (CLIA)- or International Organization for Standardization (ISO) accredited laboratory, according to one of the following: HER2 overexpression/amplification from fresh or archival tumor tissue or blood 3) Known activating HER2 mutations detected in fresh or archival tumor tissue or blood Have measurable disease per RECIST v1.1 criteria according to investigator assessment.

You may not be eligible for this study if the following are true:

  • 1) Previous treatment with HER2-directed therapy; participants with uterine serous carcinoma may have received prior trastuzumab Known hypersensitivity to any component of the drug formulation of tucatinib or trastuzumab (drug substance, excipients, murine proteins), or any component of the drug formulation of fulvestrant in participants with HR+ HER2-mutated breast cancer. 2) History of exposure to a 360 mg/m² doxorubicin-equivalent or >720 mg/m^2 epirubicin-equivalent cumulative dose of anthracyclines. 3) Treatment with any systemic anti-cancer therapy, radiation therapy, or experimental agent within =3 weeks of first dose of study treatment or are currently participating in another interventional clinical trial.

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