Last updated on January 2019

Sym015 (Anti-MET) in Patients With Advanced Solid Tumor Malignancies

Brief description of study

This is the first study to test Sym015 in humans. The primary purpose of this study is to see if Sym015 is safe and effective for patients with advanced solid tumors who do not have other available or accessible treatment options.

Detailed Study Description

In the first part of the study (Part 1, dose-escalation), Sym015 will be evaluated for safety and tolerability. Additionally, the recommended phase 2 dose (RP2D) will be determined. Sym015 will be given at different dose levels on an every second week (Q2W) dosing schedule. Each patient will be given one fixed dose level.

In the second part of the study (Part 2, dose-expansion), dosing will be at the RP2D on a Q2W dosing schedule. Two cohorts will be included:

  • Basket Cohort: Patients with KRAS wild-type (WT) advanced solid tumor malignancies with MET-amplification and without therapeutic options. Patients must have no prior therapy with MET-targeting agents, except a subset of patients having received prior therapy with a MET-targeting tyrosine kinase inhibitor (TKI).
  • Non-Small Cell Lung Carcinoma (NSCLC) Cohort: Patients with KRAS WT NSCLC with MET exon 14 skipping (METex14) mutation and without therapeutic options. Patients do not need to be MET-amplified and may have received prior therapy with a MET-targeting TKI. Patients with malignancies other than NSCLC may be considered for entry to this cohort following discussion with the Sponsor's Medical Monitor(s).

Clinical Study Identifier: NCT02648724

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University Hospitals Cleveland Medical Center

Cleveland, OH United States
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Recruitment Status: Open

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