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

NCT05427383 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2023-12-19

No results posted yet for this study

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.

Conditions

  • Stomach Cancer

Interventions

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

Sponsors & Collaborators

  • Shanghai JMT-Bio Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-07
Primary Completion
2025-11-30
Completion
2026-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05427383 on ClinicalTrials.gov