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A Phase 2 Study of Zolbetuximab as Monotherapy or in Combination with mFOLFOX6 in Subjects with Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma Whose Tumors Have High or Intermediate Claudin 18.2 Expression

Clinical Trial Details

This clinical trial is for men and women age 18 and older with metastatic or locally advanced unresectable gastric or gastro-esophageal junction (GEJ) cancer whose tumors have high or intermediate CLDN18.2 expression. 

The purpose of this study is to see if a medicine called zolbetuximab is both safe and effective as a treatment by itself and in combination with mFOLFOX6 for gastric cancer. mFOLFOX6 is currently approved by the U.S. Food and Drug Administration (FDA) and other regulatory authorities for the treatment of gastric cancer. Zolbetuximab is not an approved product by the U.S. FDA and/or any other regulatory authorities in other countries for any indication. The study drug (zolbetuximab) targets a gastric cancer specific protein named CLDN18.2 to help treat gastric cancer. Claudin 18.2 is a protein created by the CLDN18 gene and is often seen in gastric cancer. A specific lab test of your tissue is used to see if your gastric cancer has expression of the CLDN18.2 protein. The investigational lab test is called CLDN18 immunohistochemistry (IHC) companion diagnostic. 

Key Eligibility: 
  • Histologically confirmed diagnosis of metastatic or locally advanced unresectable gastric or gastroesophageal junction (GEJ) cancer. 
  • Cohort 1A/1B: Disease progression on or after at least 2 prior treatments, including fluoropyrimidine and platinum-containing chemotherapy, and if appropriate, HER2/neu-targeted therapy
  • Cohort 2: No previous systematic treatment (subject may have received neoadjuvant and/or fluorouracil-containing adjuvant chemotherapy as long as it has been completed ≥ 6 months before the first dose of study treatment). Gastric or GEJ tumor is HER2-negative
  • Detailed eligibility reviewed when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Sabrina Machado, RN
646-962-3378
sam4006@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1802019009

ClinicalTrials.gov:

NCT03505320

Sponsor:

8951-CL-0103

Status

Open to Enrollment

Age Group

Adult

Sponsor