This is a multi-centre Phase 2 study. The study will evaluate the activity and safety of AMG 337 in patients who have MET amplified gastric, gastroesophageal junction or esophageal adenocarcinoma or other MET amplified solid tumors. The study is designed to estimate the objective response rate of AMG 337 by tumor type.
This is a phase 2, multicenter, single arm, 2 cohort study to assess the safety, efficacy and pharmacokinetics of AMG 337 in MET amplified Gastric/esophageal adenocarcinoma or other solid tumors. Approximately 140 subjects will be enrolled to either Cohort 1 (subjects with MET amplified G/E adenocarcinoma with measurable tumor) or Cohort 2 (subjects with MET amplified solid tumors with measurable tumor/up to 10 subjects with MET amplified G/E adenocarcinoma with non-measurable tumor/up to 10 subjects who have received prior MET antibody therapy). All subjects will self-administer AMG 337 300 mg daily until disease progression or other protocol specified end of treatment criteria is met. Tumor tissue, biomarkers, Pharmacokinetics and Patient reported Outcomes will all be assessed. Tumor assessment by RECIST 1.1 will be followed during study treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
AMG 337 300mg orally daily.
Objective Response Rate (RECIST v1.1) in subjects with MET Amplified measurable G/GEJ/E adenocarcinoma (Cohort 1)
Determine antitumor activity of AMG 337 in subjects with MET amplified G/GEJ/E adenocarcinoma
Time frame: 2.5 years
Duration of response (cohort 1 and subjects with measurable disease at baseline in cohort 2)
Time frame: 2.5 years
Time to response (Cohort 1 and subjects with measurable disease at baseline in cohort 2)
Time frame: 2.5 years
Progression free survival
Time frame: 2.5 years
Overall survival
Time frame: 2.5 years
Incidence and severity of adverse events and significant laboratory abnormalities
Time frame: 2.5 years
AMG 337 exposure and dose intensity
Time frame: 2.5 years
Pharmacokinetic parameters
Including, but not limited to, minimum (trough) concentrations at pre-dose times, maximum concentrations (C max), the time of C max (t max), and area under the plasma concentration - time curve (AUC).
Time frame: 2.5 years
Objective Response Rate (per RECIST v1.1) in subjects with other MET amplified solid tumors (subjects with measurable disease in cohort 2).
Determine antitumor activity of AMG 337 in subjects with other MET amplified solid tumors.
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Research Site
New Haven, Connecticut, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
Rochester, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Cleveland, Ohio, United States
Research Site
Seattle, Washington, United States
Research Site
Camperdown, New South Wales, Australia
Research Site
Kurralta Park, South Australia, Australia
Research Site
Bentleigh East, Victoria, Australia
...and 87 more locations
Time frame: 2.5 years