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A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE3

A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer

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

NCT06532006•Shanghai Henlius Biotech

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (208)

Los Angeles Cancer Network

Anaheim, California, United States

OPN - Oncology Physician Network (Los Alamitos)

Los Alamitos, California, United States

Banner MD Anderson Cancer Center

Greeley, Colorado, United States

Advanced Research LLC

Deerfield Beach, Florida, United States

Florida Cancer Specialist - South

Fort Myers, Florida, United States

BRCR Medical Center

Plantation, Florida, United States

Napa Research

Pompano Beach, Florida, United States

Florida Cancer Specialist - North

St. Petersburg, Florida, United States

Florida Cancer Specialist - East

West Palm Beach, Florida, United States

Northwestern University

Chicago, Illinois, United States

Key Dates

Start Date

November 22, 2024

Primary Completion Date

June 1, 2027

Completion Date

September 1, 2028

Last Updated

February 27, 2026

Enrollment

550

ESTIMATED participants

Conditions

Gastroesophageal-junction CancerMonoclonal AntibodyGastric CancerHER2-positive Gastric Cancer

Interventions

HLX22

DRUG

Pembrolizumab

DRUG

Trastuzumab

DRUG

Oxaliplatin

DRUG

Capecitabine

DRUG

Contacts

Ying Li

CONTACT

+86 18810366427 ying_li1@henlius.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer

Inclusion Criteria

Exclusion Criteria

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