Status:
RECRUITING
A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
Lead Sponsor:
Shanghai Henlius Biotech
Collaborating Sponsors:
Henlius USA
Conditions:
Gastroesophageal-junction Cancer
Monoclonal Antibody
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
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 + chemotherap...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT06532006
Start Date
November 22 2024
End Date
September 1 2028
Last Update
August 24 2025
Active Locations (88)
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1
Los Angeles Cancer Network
Anaheim, California, United States, 92801
2
OPN - Oncology Physician Network (Los Alamitos)
Los Alamitos, California, United States, 90720
3
Banner MD Anderson Cancer Center
Greeley, Colorado, United States, 80631
4
Advanced Research LLC
Deerfield Beach, Florida, United States, 33064