A Phase II Study of IMAB362 in Patients with Advanced Inoperable Stomach Cancer

Print

Full Title

A Phase 2 Study of IMAB362 as Monotherapy or in Combination with mFOLFOX6 in Subjects with Metastatic or Locally Advanced Unresectable Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma whose Tumors have High or Intermediate Claudin (CLDN) 18.2 Expression

Purpose

The purpose of this study is to evaluate the safety and effectiveness of the investigational drug IMAB362 when given alone or in combination with standard mFOLFOX6 chemotherapy (leucovorin calcium, fluorouracil, and oxaliplatin) in patients with inoperable or metastatic stomach cancer or cancer of the gastroesophageal junction (GEJ). IMAB362 targets a protein called CLDN18.2, which is commonly found on tumor cells of stomach and/or GEJ cancers.

Researchers think that giving IMAB362 alone or in combination with mFOLFOX6 will help target the chemotherapy to selectively attack cancer cells, and slow or prevent the growth of cancer. Patients in this study will receive IMAB362 alone or in combination with mFOLFOX6. The treatments in this study are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic gastric or GEJ cancer that is positive for the CLDN18.2 protein.
  • Patients must recover from the serious side effects of prior therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. David Ilson at 646-888-4183.

Protocol

18-532

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators