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Astellas: A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2-Positive, HER2- Negative, Locally A

General Information

Age Group

Adult

Status

Active

Protocol Number

NCT03504397

Background Information

The purpose of this study is to see if an Investigational study drug, called zolbetuximab (IMAB362), is both safe and effective as a treatment in combination with the chemotherapy regimen mFOLFOX6 for gastric and GEJ Cancer (The Gastroesophageal junction is the place where the esophagus connects to the stomach).

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital

Eligibility Information

  • Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.
  • Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to the first dose of study treatment.
  • Additional eligibility in protocol.

Ineligibility Information

  • Subject has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant chemotherapy as long as it was completed at least 6 months prior to the first dose of study treatment. Subject may have received treatment with herbal medications that have known antitumor activity > 28 days prior to first dose of study treatment.
  • Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma unless the radiotherapy was completed >28 days prior to start of study treatment. Subject who received palliative radiotherapy to peripheral bone metastases ≥14 days prior to start of study treatment and has recovered from all acute toxicities is allowed.
  • Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to first dose of study treatment. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone) or a single dose of systemic corticosteroids are allowed.
  • Subject has received other investigational agents or devices within 28 days prior to first dose of study treatment.
  • Additional ineligibility in protocol.

For more information go to: https://clinicaltrials.gov/ct2/show/NCT03504397