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8110 Gatehouse Road, Falls Church, VA 22042

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 Advanced Unr

General Information

Age Group

Adult

Status

Recruiting

Protocol Number

NCT03504397

Background Information

This global, multi-center, double-blind, 1:1 randomized, phase 3 study will evaluate efficacy of zolbetuximab plus mFOLFOX6 versus placebo plus mFOLFOX6 as first-line treatment in subjects with CLDN18.2-positive, HER2-negative locally advanced unresectable or metastatic gastric and GEJ adenocarcinoma.

Offered At

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

Eligibility Information

  • Participant has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma
  • Participant has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to the first dose of study treatment
  • For participants with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy
  • Participant has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen
  • Additional inclusions in protocol

Ineligibility Information

  • Participant 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
  • Participant 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.
  • Participant has known dihydropyrimidine dehydrogenase (DPD) deficiency (NOTE: screening for DPD deficiency should be conducted per local requirements.)
  • Participant has gastric outlet syndrome or persistent/recurrent vomiting
  • Participant has an active autoimmune disease that has required systemic treatment within the past 2 years
  • Participant has significant cardiovascular disease
  • Additional exclusions in protocol

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