A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer

This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by

Trial Details

NCT ID
NCT06532006
Phase
PHASE3
Sponsor
Shanghai Henlius Biotech
Status
RECRUITING
Cancer Type
Gastric Cancer
Interventions
  • HLX22
  • Pembrolizumab
  • Trastuzumab
  • Oxaliplatin
  • Capecitabine
Locations (sample)
  • Anaheim, California, United States|33.83529,-117.9145
  • Los Alamitos, California, United States|33.80307,-118.07256
  • Greeley, Colorado, United States|40.42331,-104.70913
  • Deerfield Beach, Florida, United States|26.31841,-80.09977
  • Fort Myers, Florida, United States|26.62168,-81.84059

Key Eligibility Criteria

  • Male/female who are at least 18 years of age on the day of signing the informed consent.
  • With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric…
  • Had measurable disease as assessed by IRRC according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
  • HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ or FISH, as assessed by a central laboratory on a primary or metast…

For full eligibility, visit ClinicalTrials.gov.

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