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8951-CL-0301 (Spotlight): A study to assess the efficacy of IMAB362 plus mFOLFOX6 compared with placebo plus mFOLFOX6 as first-line treatment of subjects with claudin (CLDN) 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma

Description

The purpose of this study is to evaluate the efficacy of IMAB362 plus mFOLFOX6 compared with placebo plus mFOLFOX6 (as first-line treatment) as measured by progression-free survival in participants with claudin (CLDN) 18.2 positive, HER2-negative locally advanced unresectable or metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma.

This study will also evaluate efficacy, safety and tolerability of IMAB362, as well as its effects on quality of life. Pharmacokinetics of IMAB362 and the immunogenicity profile of IMAB362 will be evaluated as well.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective is to evaluate the efficacy of IMAB362 plus mFOLFOX6 compared with placebo plus mFOLFOX6 (as first-line treatment) as measured by progression-free survival (PFS) in subjects with claudin (CLDN) 18.2 positive, human epidermal growth factor receptor 2 (HER2)–negative, locally advanced unresectable or metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Have histologically confirmed diagnosis of gastric or GEJ adenocarcinoma
  • Have radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to the first dose of study treatment
  • Have measurable disease according to RECIST 1.1 within 28 days prior to the first dose of study treatment (For subjects 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.)
  • Have a tumor that expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing
  • Have a HER2-negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen
  • Have ECOG performance status 0 to 1
  • Have predicted life expectancy ≥ 12 weeks
  • Meet all the above criteria based on the centrally analyzed laboratory tests within 14 days prior to the first dose of study treatment

Excluding patients who:

  • Have 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 six months prior to the first dose of study treatment.)
  • Have received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma unless the radiotherapy was completed within 28 days prior to start of study treatment (Subjects who received palliative radiotherapy to peripheral bone metastases ≥14 days prior to start of study treatment and have recovered from all acute toxicities are allowed.)
  • Have 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] are allowed.)
  • Have received other investigational agents or devices within 28 days prior to first dose of study treatment
  • Have had prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies
  • Have known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment
  • Have prior severe allergic reaction or intolerance to any component of mFOLFOX6
  • Have known dihydropyrimidine dehydrogenase deficiency
  • Have gastric outlet syndrome or persistent/recurrent vomiting
  • Have recent gastric bleeding or symptomatic subjects with proven gastric ulcers that would exclude the subject from participation
  • Have a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen (HBs Ag)) or hepatitis C infection (For subjects who are negative for HBs Ag, but hepatitis B core antibody [HBc Ab] positive, an HB deoxyribonucleic acid [DNA] test will be performed, and if positive, the subject will be excluded. Subjects with positive serology but negative hepatitis C virus (HCV) ribonucleic acid (RNA) test results are eligible.)
  • Have an active autoimmune disease that has required systemic treatment within the past two years
  • Have active infection requiring systemic therapy that has not completely resolved within 14 days prior to start of study treatment
  • Have significant cardiovascular disease, including:
    • Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within six months prior to administration of first dose of study drug
    • History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes)
    • QTc interval > 450 msec
    • Cardiac arrhythmias requiring anti-arrhythmic medications (Subjects with rate controlled atrial fibrillation for > 1 month prior to first dose of study drugs are eligible.)
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Accepting new patients

 

Learn more at

clinicaltrials.gov

 

Principal Investigator(s)

Arturo Loaiza-Bonilla

Alan Tan