Study on Bemarituzumab with Other Cancer Treatments for Advanced Stomach or Gastroesophageal Junction Cancer

Sponsor: Amgen

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05322577

This clinical trial is testing the safety and effectiveness of a new drug, bemarituzumab, when used with other cancer treatments in patients with advanced stomach or gastroesophageal junction cancer that has not been treated before.

Patient Parameters

Program Overview

The study aims to find out if bemarituzumab, when combined with other cancer treatments like S-1, oxaliplatin (SOX), and nivolumab, is safe and can effectively reduce tumors in patients with advanced stomach or gastroesophageal junction cancer. Researchers will assess how well the combination works by measuring the response of the cancer to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults with advanced stomach or gastroesophageal junction cancer that cannot be removed by surgery.
  • Able to provide a tumor sample, either from a previous test within the last 6 months or a new biopsy.
  • For some parts of the study, the cancer must show a specific marker called FGFR2b.
  • Good overall health with an ECOG performance score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Cancer that can be measured or evaluated by standard criteria.
  • No issues with receiving the combination of treatments being tested.
  • Adequate organ function as determined by medical tests.
  • For certain parts of the study, the cancer must be measurable by specific criteria.

Exclusion Criteria

  • Previous treatment for advanced or inoperable cancer (except if prior treatment for local disease ended more than 6 months ago).
  • Previous treatment with drugs targeting the FGF-FGFR pathway.
  • Cancer that is HER2 positive.
  • Untreated or symptomatic brain cancer or central nervous system disease.
  • Severe nerve damage.
  • Significant heart disease.
  • Other cancers within the last 2 years, unless fully treated.
  • Chronic eye diseases.
  • Major surgery or participation in another study within 28 days before starting this study.
  • Recent palliative radiotherapy within 14 days before starting this study.
  • Eye conditions that increase the risk of corneal ulcers.
  • Systemic diseases or eye disorders requiring long-term use of eye steroids.

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