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A Study of KN026-based Combination Therapy in HER2-positive Gastric Cancer

NCT07332533 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 490

Last updated 2026-01-12

No results posted yet for this study

Summary

This study is designed to compare the efficacy and safety of KN026 combined chemotherapy with or without Enlonstobart versus Trastuzumab combined chemotherapy with or without Pembrolizumab as first-line treatment in HER2-positive unresectable locally advanced or metastatic gastric cancer.

Conditions

  • HER2-positive Gastric Cancer

Interventions

DRUG

KN026

In accordance with the protocol

DRUG

Capecitabine

Capecitabine is for oral administration.

DRUG

Enlonstobart

Enlonstobart is administered by intravenous infusion.

DRUG

Oxaliplatin

Oxaliplatin is administered by intravenous infusion.

DRUG

Trastuzumab

Trastuzumab is administered by intravenous infusion.

DRUG

Pembolizumab

Pembolizumab is administered by intravenous infusion.

DRUG

Cisplatin

Cisplatin is administered by intravenous infusion.

DRUG

Fluorouracil

Fluorouracil is administered by intravenous infusion.

Sponsors & Collaborators

  • Shanghai JMT-Bio Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-30
Primary Completion
2032-06-30
Completion
2032-12-31

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Entities

Drugs

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 NCT07332533 on ClinicalTrials.gov