A Phase 2 Study of IMAB362 as Monotherapy or in Combination With mFOLFOX6 in Subjects With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Whose Tumors Have High or Intermediate Claudin (CLDN) 18.2 Expression

B
Bert O'Neil, MD

Primary Investigator

Overview

The purpose of this study is to determine the Objective Response Rate (ORR) of IMAB362 as a single agent as assessed by an independent central reader. This study will also assess the ORR and Progression Free Survival (PFS) of IMAB362 in combination with mFOLFOX6, assess the safety and tolerability, assess the effects on CLDN18.2 expression and assess the immunogenicity and immunomodulatory effects of IMAB362 as a single agent and in combination with mFOLFOX6. This study will also evaluate the pharmacokinetics (PK) of IMAB362, oxaliplatin and fluorouracil (5-FU), evaluate health-Related Quality of Life (HRQoL), evaluate the Disease Control Rate (DCR), Duration of Response (DOR), PFS and Overall Survival (OS) of IMAB362 as a single agent.

Description

This is a study to assess the antitumor activity of IMAB362, an Immunoglobulin (IgG1) chimeric monoclonal antibody directed against CLDN18.2, in subjects with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors have high or intermediate CLDN18.2 expression.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Gastric Cancer,stomach cancer,Gastro-esophageal Junction (GEJ) Cancer
  • Age: Between 18 Years - 100 Years
  • Gender: All

Inclusion Criteria
Has histologically confirmed gastric or GEJ adenocarcinoma
Exclusion Criteria
Has had prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies
Has known immediate or delayed hypersensitivity or contraindication to any component of study treatment
Has gastric outlet syndrome or persistent recurrent vomiting
Has known active central nervous system metastases and/or carcinomatous meningitis
Has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen [HBsAg]) or hepatitis C infection
Has active infection requiring systemic therapy
Has active autoimmune disease that has required systemic treatment in the past 2 years


Additional Information:

Updated on 26 Apr 2024. Study ID: 1803653722 (8951-CL-0103)

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