Clinical trial · Interventional
A Phase 1/2 Study Evaluating AMG 337 in Asian Subjects
A Multicenter, Phase 1/2, Open-Label Study Evaluating the Tolerability, Safety, Pharmacokinetics, and Efficacy of AMG 337 in Asian Subjects
NCT02096666CI-TRIAL-00055681completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter, Phase 1/2 study. The study will evaluate the tolerability, safety and activity of AMG 337 in Asian subjects who have advanced solid tumors (Phase 1) or subjects with MET amplified tumors with a focus on gastric/gastroesophageal junction/esophageal adenocarcinoma (Phase 2).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 337 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- interventionNames
- Drug: AMG 337
Primary outcomes (2)
- measure
- Phase 1- Adverse events and clinical laboratory abnormalities
- timeFrame
- 17 months
- description
- Adverse events and clinical laboratory abnormalities defined as DLTs.
- measure
- Phase 2- Overall Response Rate (per RECIST v1.1) in subjects with MET amplified measurable gastric/gastroesophageal junction/esophageal adenocarcinoma (cohort 1)
- timeFrame
- 17 months
- description
- Determine anti-tumor activity of AMG 337 in subjects with MET amplified gastric/gastroesophageal junction/esophageal adenocarcinoma (cohort 1)
Secondary outcomes (15)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Able to self administer daily AMG 337 as a whole capsule * Male or female 20 years of age or over * Phase 1: Subjects must have a pathologically confirmed, advanced solid tumor for which the subjects have received prior therapy for advanced disease, for which no standard therapy exists, or the subject refuses standard therapy. * Phase 2: Subjects must have a pathologically confirmed, advanced G/GEJ/E adenocarcinoma (cohort 1) or other solid tumor (cohort 2) for which the subjects have received prior therapy for advanced disease, or for which no standard therapy exists, or the subject refuses standard therapy. * Tumor MET amplified by protocol-specified centralized testing (phase 2 only). * Phase 1: Measurable or non-measurable disease per RECIST v1.1 * Phase 2: Measurable disease per RECIST v1.1 guidelines. Cohort 2 may include subjects with advanced MET amplified G/GEJ/E adenocarcinoma with non-measurable tumor per RECIST v1.1. * (ECOG) Performance Status of 0, 1, or 2 * Other protocol defined inclusion criteria may apply. Exclusion Criteria: * Known central nervous system metastases. * Subject is a candidate for curative surgery or definitive chemoradiation. * Peripheral edema \> grade 1. * Subjects who have persistent gastric outlet obstruction, complete dysphagia or are dependent upon jejunostomy for feeding. Significant gastrointestinal disorder(s) that in the opinion of the Investigator may influence drug absorption. * Currently receiving any anti-tumor treatments, or less than 14 days prior to enrollment since ending anti-tumor treatment. * Prior treatment with small molecule inhibitors of the MET pathway. * Other protocol defined exclusion criteria may apply.
References
Publications (1)
- BACKGROUNDYasui H, Go N, Yang H, Amore BM, Jung AS, Doi T. A Phase 1 study evaluating AMG 337 in Asian patients with advanced solid tumors. Jpn J Clin Oncol. 2017 Aug 1;47(8):772-776. doi: 10.1093/jjco/hyx067. PMID 28582510