Trial Identifiers
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Scientific Title
A Phase 1b/2 Study of Derazantinib as Monotherapy and Combination Therapy With Paclitaxel, Ramucirumab or Atezolizumab in Patients With HER2-negative Gastric Adenocarcinoma Expressing FGFR2 Genetic Aberrations
Commercial Sponsor
Basilea Pharmaceutica
Summary
The study comprises three open-label sub-studies in patients with HER2-negative adenocarcinoma of the stomach or gastro-oesophageal junction, harbouring FGFR2 gene translocations, FGFR2 gene amplifications, or FGFR1-3 mutations. Patients will be treated with single-agent derazantinib or derazantinib in combination with paclitaxel, ramucirumab, or atezolizumab. The study will enrol patients with either metastatic or recurrent locally advanced HER2-negative stomach or gastro-oesophageal junction cancers that are inoperable at the time of screening, and have radiologically confirmed disease progression after one or at least one standard treatment regimen.