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

Recruiting now · Phase 3

Conditions studied: Gastroesophageal-junction Cancer, Monoclonal Antibody, Gastric Cancer, HER2-positive Gastric Cancer

In brief

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).

Key facts

Study ID

NCT06532006

Run by

Shanghai Henlius Biotech

People needed

550

Starts

2024-11-22

Expected to finish

2028-09-01

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male/female who are at least 18 years of age on the day of signing the informed consent.
• With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
• Had measurable disease as assessed by IRRC according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
• 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.
• ECOG PS within 7 days before randomization: 0-1.
• Expected survival ≥ 6 months.
• Had adequate organ function

You may not qualify if…

• Patients with other malignant tumors within 2 years before the randomization.
• 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.
• Previous treatment with any HER2-target therapy.
• Active gastrointestinal bleeding
• Presence of central nervous system (CNS) metastases.
• Left ventricular ejection fraction (LVEF) < 55%.
• Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.

Where it is running

• OPN - Oncology Physician Network (Los Alamitos) — Los Alamitos, California, United States (enrolling)
• Banner MD Anderson Cancer Center — Greeley, Colorado, United States (enrolling)
• Advanced Research LLC — Deerfield Beach, Florida, United States (enrolling)
• Florida Cancer Specialist - South — Fort Myers, Florida, United States (enrolling)
• BRCR Medical Center — Plantation, Florida, United States (enrolling)
• Napa Research — Pompano Beach, Florida, United States (enrolling)
• Florida Cancer Specialist - North — St. Petersburg, Florida, United States (enrolling)
• Florida Cancer Specialist - East — West Palm Beach, Florida, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• University of Chicago — Chicago, Illinois, United States (enrolling)
• Mission Cancer + Blood (Exigent Network) — Des Moines, Iowa, United States (enrolling)
• Holden Comprehensive Cancer Center - University of Iowa — Iowa City, Iowa, United States (enrolling)
• Washington University School of Medicine St. Louis — St Louis, Missouri, United States (enrolling)
• Nebraska Cancer Specialists — Omaha, Nebraska, United States (enrolling)
• Comprehensive Cancer Centers Nevada — Las Vegas, Nevada, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Guthrie Medical Group, PC and Robert Packer Hospital (Guthrie Cancer Center - Sayre) — Sayre, Pennsylvania, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• HCA Midwest Health — Nashville, Tennessee, United States (enrolling)
• Texas Oncology - West (SCRI) — Abilene, Texas, United States (enrolling)
• Texas Oncology Central South (SCRI) — Austin, Texas, United States (enrolling)
• Texas Oncology Northeast (SCRI) — Denton, Texas, United States (enrolling)
• The University of Texas MD Anderson cancer Center — Houston, Texas, United States (enrolling)
• Los Angeles Cancer Network — Anaheim, California, United States (enrolling)

Full record on ClinicalTrials.gov

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