KN026 in Combination With Chemotherapy in HER2 Positive Gastric Cancer Subjects Who Have Failed First-line Therapy
A Randomized, Multicenter, Phase Ⅱ/Ш Clinical Study to Evaluate the Efficacy of KN026 in Combination With Chemotherapy in Subjects With HER2 Positive Advanced Unresectable or Metastatic Gastric Cancer (Including Gastro-esophageal Junction Adenocarcinoma) Who Have Failed First-line Therapy.
Shanghai JMT-Bio Inc.
286 participants
Apr 7, 2022
INTERVENTIONAL
Conditions
Summary
KN026-001 is a two-stage study (Open-label stage/Randomized stage). Open-label stage is designed to evaluate the safety and efficacy of KN026 and chemotherapy when given together. Randomized stage is designed to evaluate the OS and PFS in patients receiving KN026 and chemotherapy compared to patients receiving placebo and chemotherapy.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
IV KN026/Placebo at 30 mg/kg on D1, Q3W
IV Paclitaxel at 175 mg/m² on D1, Q3W
IV Docetaxel at 75 mg/m² on D1, Q3W
IV Irinotecan at 125 mg/m² on D1, D8, Q3W
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05427383