NCT05427383

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.

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 286 (estimated)
• Sponsor: Shanghai JMT-Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Stomach Cancer

Interventions

Type	Name	Description
DRUG	KN026/Placbo Injection	IV KN026/Placebo at 30 mg/kg on D1, Q3W
DRUG	Paclitaxel Injection	IV Paclitaxel at 175 mg/m² on D1, Q3W
DRUG	Docetaxel Injection	IV Docetaxel at 75 mg/m² on D1, Q3W
DRUG	Irinotecan Injection	IV Irinotecan at 125 mg/m² on D1, D8, Q3W

Timeline

• Start date: 2022-04-07
• Primary completion: 2025-11-01
• Completion: 2026-11-01
• First posted: 2022-06-22
• Last updated: 2023-12-19

Locations

1 site across 1 country: China