Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Seagen Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically confirmed diagnosis of locally-advanced unresectable or metastatic HER2+ gastric or gastroesophageal junction adenocarcinoma (GEC)
HER2+ disease documented since progression of the most recent line of systemic therapy, as follows:
* Phase 2 paclitaxel dose optimization stage:
* HER2 amplification in a blood-based NGS assay performed at a central laboratory, or
* HER2 overexpression/amplification immunohistochemistry (IHC) and in situ hybridization (ISH) (IHC3+ or IHC2+/ISH+) assay of a tumor tissue sample
* Phase 2 dose expansion stage:
* Cohort 2A: HER2 amplification in a blood-based NGS assay performed at a central laboratory
* Cohort 2B: No HER2 amplification by blood-based NGS assay, but HER2 overexpression/amplification by IHC and ISH (IHC3+ or IHC2+/ISH+) assay of a tumor tissue sample
* Phase 3: HER2 amplification in a blood-based NGS assay performed at a central laboratory
History of prior treatment with a HER2-directed antibody
Progressive disease during or after first-line therapy for locally-advanced unresectable or metastatic GEC
Phase 2: Measurable disease according to RECIST version 1.1
Phase 3: Measurable or non-measurable disease according to RECIST version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Life expectancy of at least 3 months, in the opinion of the investigator
You may not be if
Subjects with squamous cell or undifferentiated GEC
Having received more than 1 line of prior systemic therapy for locally-advanced unresectable or metastatic disease
Having received taxanes ≤12 months prior to enrollment, prior treatment with ramucirumab, or prior treatment with tucatinib, lapatinib, neratinib, afatinib, or any other investigational anti-HER2 and/or anti-EGFR tyrosine kinase inhibitor, or with T-DM1, T-Dxd, or any other HER2-directed antibody-drug conjugate
Phase 2 paclitaxel dose optimization stage only: history of prior partial or total gastrectomy
Unable to swallow pills
Clareo Health | Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer
