RecruitingPhase 2Phase 3NCT05427383

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.


Sponsor

Shanghai JMT-Bio Inc.

Enrollment

286 participants

Start Date

Apr 7, 2022

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called KN026 — which targets a protein called HER2 on cancer cells — combined with chemotherapy is effective for people with HER2-positive stomach or gastroesophageal junction cancer whose cancer grew during or after their first treatment. **You may be eligible if:** - You are at least 18 years old - You have confirmed HER2-positive advanced stomach or gastroesophageal junction cancer - Your cancer progressed during or after a first-line treatment that included trastuzumab and chemotherapy - Your performance status is adequate (ECOG 0–1) - Your life expectancy is at least 3 months - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if:** - You have not tried any prior treatment for advanced gastric cancer - Your organ function is significantly impaired - You have other serious active conditions that would make treatment unsafe Talk to your doctor to see if this trial is right for you.

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

DRUGKN026/Placbo Injection

IV KN026/Placebo at 30 mg/kg on D1, Q3W

DRUGPaclitaxel Injection

IV Paclitaxel at 175 mg/m² on D1, Q3W

DRUGDocetaxel Injection

IV Docetaxel at 75 mg/m² on D1, Q3W

DRUGIrinotecan Injection

IV Irinotecan at 125 mg/m² on D1, D8, Q3W


Locations(1)

Chinese PLA General Hospital

Beijing, China

View Full Details on ClinicalTrials.gov

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NCT05427383


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