RecruitingInterventionalPhase 3

A Randomized, Double-blinded, Multicenter, Phase Ⅲ Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer

NCT ID: NCT06532006Sponsor: Shanghai Henlius BiotechLast updated: 2026-02-27

Summary

This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).

Detailed description

In experimental group: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) ± placebo (for pembrolizumab), once every 3 weeks (Q3W). In control group: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) ± pembrolizumab, Q3W.

Arms & interventions

DrugHLX22
HLX22 15mg/kg Q3w
DrugPembrolizumab
Pembrolizumab 200mg q3w
DrugTrastuzumab
Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance thereafter ,Q3W
DrugOxaliplatin
Oxaliplatin 130 mg/m2 ,Q3W
DrugCapecitabine
Capecitabine 1000 mg/m2 bid on Days 1-14 ,Q3W

Outcome measures

Primary

Progression-Free Survival (PFS)per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee)
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm
Time frame: Up to 5 years
Overall Survival （OS）
OS is defined as the time from randomization to death due to any cause. OS will be determined for each treatment arm.
Time frame: Up to 5 years

Secondary

PFS per RECIST 1.1 assessed by investigator
Time frame: Up to 5 years
Objective Response Rate (ORR) assessed by IRRC and investigator per RECIST v1.1
Time frame: Up to 5 years
Adverse events (AE)
Time frame: Up to 5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

Inclusion Criteria: 1. Male/female who are at least 18 years of age on the day of signing the informed consent. 2. With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. 3. Had measurable disease as assessed by IRRC according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only. 4. HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ or FISH, as assessed by a central laboratory on a primary or metastatic tumor. 5. ECOG PS within 7 days before randomization: 0-1. 6. Expected survival ≥ 6 months. 7. Had adequate organ function Exclusion Criteria: 1. Patients with other malignant tumors within 2 years before the randomization. 2. Evidence of disease progression within 6 months (before randomization) after completion of prior neoadjuvant or adjuvant chemotherapy (or both) or radiotherapy for gastric adenocarcinoma or gastroesophageal junction adenocarcinoma. 3. Previous treatment with any HER2-target therapy. 4. Active gastrointestinal bleeding 5. Presence of central nervous system (CNS) metastases. 6. Left ventricular ejection fraction (LVEF) \< 55%. 7. Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.

Study locations (29)

Los Angeles Cancer Network

Anaheim, California, 92801

Recruiting

OPN - Oncology Physician Network (Los Alamitos)

Los Alamitos, California, 90720

Recruiting

Banner MD Anderson Cancer Center

Greeley, Colorado, 80631

Recruiting

Advanced Research LLC

Deerfield Beach, Florida, 33064

Recruiting

Florida Cancer Specialist - South

Fort Myers, Florida, 33901

Recruiting

BRCR Medical Center

Plantation, Florida, 33322

Recruiting

Napa Research

Pompano Beach, Florida, 33064

Recruiting

Florida Cancer Specialist - North

St. Petersburg, Florida, 33705

Recruiting

Florida Cancer Specialist - East

West Palm Beach, Florida, 33401

Recruiting

Northwestern University

Chicago, Illinois, 60611

Recruiting

University of Chicago

Chicago, Illinois, 60637

Recruiting

Mission Cancer + Blood (Exigent Network)

Des Moines, Iowa, 50309

Recruiting

Holden Comprehensive Cancer Center - University of Iowa

Iowa City, Iowa, 52242

Recruiting

Washington University School of Medicine St. Louis

St Louis, Missouri, 63110

Recruiting

Nebraska Cancer Specialists

Omaha, Nebraska, 68130

Recruiting

Comprehensive Cancer Centers Nevada

Las Vegas, Nevada, 89169

Recruiting

Cleveland Clinic

Cleveland, Ohio, 44195

Recruiting

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Recruiting

Guthrie Medical Group, PC and Robert Packer Hospital (Guthrie Cancer Center - Sayre)

Sayre, Pennsylvania, 18840

Recruiting

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Recruiting

HCA Midwest Health

Nashville, Tennessee, 60637

Recruiting

Texas Oncology - West (SCRI)

Abilene, Texas, 79606

Recruiting

Texas Oncology Central South (SCRI)

Austin, Texas, 78705

Recruiting

Texas Oncology Northeast (SCRI)

Denton, Texas, 76201

Recruiting

The University of Texas MD Anderson cancer Center

Houston, Texas, 77030

Recruiting

Texas Oncology - Gulf Coast (SCRI)

Webster, Texas, 77598

Recruiting

American Oncology Network Vista Oncology Division

Olympia, Washington, 98502

Recruiting

Northwest Medical Specialties

Tacoma, Washington, 98405

Recruiting

West Virginia University Cancer Institute

Morgantown, West Virginia, 26506

Recruiting