Solid Tumor Clinical Trial
Official title:
A Phase 2 Study of AMG 337 in Subjects With Advanced or Metastatic Solid Tumors That Overexpress Mesenchymal Epithelial Transition (MET) or Harbor MET Exon 14 Skipping (METex14del) Mutations
This is a phase 2 study of AMG 337 in subjects with advanced or metastatic solid tumors that overexpress MET or harbor METex14del mutations resulting in MET exon 14 skipping.
This is a phase 2, two-cohort, single-arm open-label study that will assess the efficacy of
AMG 337 based on ORR in subjects with advanced or metastatic solid tumors that overexpress
MET or harbor METex14del mutations resulting in MET exon 14 skipping. MET overexpression will
be determined by quantitative proteomics with mass spectrometry. METex14del mutations
resulting in MET exon 14 skipping will be determined by DNA sequencing and confirmed with RNA
sequencing. Subjects will be enrolled as follows:
- Cohort 1: Subjects with advanced or metastatic solid tumors that overexpress MET
- Cohort 2: Subjects with advanced or metastatic solid tumors that harbor METex14del
mutations Simon's two-stage optimal design will be utilized separately for each cohort
to assess the primary efficacy endpoint ORR. The null hypothesis of Simon's two-stage
design states that the ORR will be ≤ 10% (poor response) and will be tested against a
one-sided alternative.
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