NCT03147976

QUILT-3.036: AMG 337 in Subjects With Advanced or Metastatic Solid Tumors

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NantPharma, LLC · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	AMG 337	6-{(1R)-1-\[8-fluoro-6-(1-methyl-1H-pyrazol-4- yl)\[1,2,4\]triazolo\[4,3-a\]pyridin-3-yl\]ethyl}-3-(2- methoxyethoxy)-1,6-naphthyridin-5(6H)-one•hydrate (1:1)

Timeline

• Start date: 2018-05-02
• Primary completion: 2019-08-23
• Completion: 2019-08-23
• First posted: 2017-05-10
• Last updated: 2019-08-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study