A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
Sponsor: Shanghai Henlius Biotech
ClinicalTrials ID:NCT06532006
This Phase III study evaluates HLX22 with trastuzumab and chemotherapy in HER2-positive G/GEJ cancer. Participants, aged 18+, with advanced/metastatic adenocarcinoma, ECOG 0-1, and adequate organ function, are randomized 1:1. The experimental group receives HLX22, trastuzumab, and XELOX ± placebo; the control group receives placebo, trastuzumab, and XELOX ± pembrolizumab.
Patient Parameters
| Parameter | Options |
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Program Overview
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).
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 Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Los Angeles Cancer Network | 92801 | Anaheim | California |
| OPN - Oncology Physician Network (Los Alamitos) | 90720 | Los Alamitos | California |
| Banner MD Anderson Cancer Center | 80631 | Greeley | Colorado |
| Advanced Research LLC | 33064 | Deerfield Beach | Florida |
| Florida Cancer Specialist - South | 33901 | Fort Myers | Florida |
| BRCR Medical Center | 33322 | Plantation | Florida |
| Napa Research | 33064 | Pompano Beach | Florida |
| Florida Cancer Specialist - North | 33705 | St. Petersburg | Florida |
| Florida Cancer Specialist - East | 33401 | West Palm Beach | Florida |
| Northwestern University | 60611 | Chicago | Illinois |
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