A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.

Launched by AMGEN · Apr 4, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called bemarituzumab, which will be given alongside other cancer therapies for patients with advanced gastric (stomach) or gastroesophageal junction cancer. The main goals are to see how safe and tolerable bemarituzumab is when combined with standard treatments, and to measure how effective it is in shrinking tumors. The trial is currently recruiting participants aged 18 and older who have not received prior treatment for their advanced cancer and can provide a tumor sample for testing.

If you or a loved one are considering joining this trial, you will need to meet certain criteria, such as having advanced cancer that cannot be surgically removed, being in decent overall health, and having measurable disease based on specific medical guidelines. Participants can expect close monitoring during the trial to ensure their safety and to evaluate how well the treatment is working. It's important to know that there are some exclusions, like having certain other health conditions or prior treatments that could affect eligibility. This trial aims to explore a potential new approach to treating difficult-to-manage cancers, offering hope for improved outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amendable to curative therapy.
• • Ability to provide tumor sample, either archival (obtained within 6 months to joining study) or fresh biopsy.
• • For certain arms for Part 1, FGFR2b overexpression positive defined as any FGFR2b 2+/3+ TC determined by centrally performed immunohistochemistry (IHC), based on tumor sample provided.
• • For Part 2, FGFR2b overexpression positive defined as FGFR2b ≥10% 2+/3+ TC determined by centrally performed IHC testing, based on tumor sample provided.
• • Easter Cooperative Oncology Group (ECOG) performance score less than or equal to 1.
• • Measurable or non-measurable disease as long as evaluable by Response Evaluation Criteria Solid Tumors (RECIST) version 1.1
• • Participant has no contradictions to CAPOX/SOX plus or minus nivolumab.
• • Adequate organ function.
• • For Part 2, measurable disease according to RECIST v1.1.
• Exclusion Criteria:
• • Prior treatment for metastatic or unresectable disease (Note: prior adjuvant or neo-adjuvant therapy for local disease is allowed if ended more than 6 months of 1st dose).
• • Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway.
• • Known human epidermal growth factor receptor 2 (HER2) positive
• • Untreated or symptomatic central nervous system (CNS) disease or brain metastases.
• • Peripheral sensory neuropathy greater than or equal to Grade 2.
• • Clinically significant cardiac disease.
• • Other malignancy within the last 2 years (exceptions for definitively treated disease).
• • Chronic or systemic ophthalmological disorders.
• • Major surgery or other investigational study within 28 days of first study treatment dose.
• • Palliative radiotherapy within 14 days of first study treatment dose.
• • Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.
• • History or evidence of systemic disease or ophthalmological disorders requiring chronic use of ophthalmic corticosteroids.