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KN026 in Combination With Chemotherapy in HER2 Positive Gastric Cancer Subjects Who Have Failed First-line Therapy

Stomach Cancer Clinical Trial

Official title:
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.

Clinical Trial 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.

Clinical Trial Description

KN026-001 is a two-stage randomized, multicenter, phase Ⅱ/Ⅲ clinical study to evaluate the efficacy of KN026 in combination with chemotherapy in subjects with HER2-positive advanced unresectable or metastatic gastric cancer, including adenocarcinoma of the gastro-esophageal junction, who have failed first-line therapy. Stage 1 is an open-label, multicenter, phase Ⅱ study to evaluate the safety and ORR in subjects receiving KN026 in combination with chemotherapy. Stage 2 is a randomized, double-blind, placebo-controlled phase Ш study to evaluate the OS and PFS in subjects receiving KN026 in combination with chemotherapy compared to placebo in combination with chemotherapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05427383
Study type Interventional
Source Shanghai JMT-Bio Inc.
Contact
Status Recruiting
Phase Phase 2/Phase 3
Start date April 7, 2022
Completion date November 2026
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