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

Part of paid clinical trials in Anaheim, California.

Sponsor
Shanghai Henlius Biotech
Study ID
NCT06532006
Phase
PHASE3
Status
Recruiting
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Conditions

  • Gastric Cancer
  • Gastroesophageal-junction Cancer
  • HER2-positive Gastric Cancer
  • Monoclonal Antibody

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HLX22 — DRUG
    HLX22 15mg/kg Q3w
  • Pembrolizumab — DRUG
    Pembrolizumab 200mg q3w
  • Trastuzumab — DRUG
    Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance thereafter ,Q3W
  • Oxaliplatin — DRUG
    Oxaliplatin 130 mg/m2 ,Q3W
  • Capecitabine — DRUG
    Capecitabine 1000 mg/m2 bid on Days 1-14 ,Q3W

Study Details

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 Dates

Start date
Nov 22, 2024
Status verified
Dec 2025
Primary completion
Jun 1, 2027
Completion
Sep 1, 2028

Study Design

Enrollment
550 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    Experimental group: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) ± placebo (for pembrolizumab), Q3W Subjects in the experimental group may use one of the treatments below: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) or HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) + placebo (for pembrolizumab)
  • Active Comparator: Control group
    Control group: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) ± pembrolizumab, Q3W Subjects in the control group may use one of the treatments below: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) or Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) + pembrolizumab

Primary Outcome Measure

Progression-Free Survival (PFS)per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee) [ Time Frame: Up to 5 years ]

Central Contacts

Locations (29)

FacilityCityStateZIPSite coordinators
Los Angeles Cancer NetworkAnaheimCalifornia92801-
OPN - Oncology Physician Network (Los Alamitos)Los AlamitosCalifornia90720-
Banner MD Anderson Cancer CenterGreeleyColorado80631-
Advanced Research LLCDeerfield BeachFlorida33064-
Florida Cancer Specialist - SouthFort MyersFlorida33901-
BRCR Medical CenterPlantationFlorida33322-
Napa ResearchPompano BeachFlorida33064-
Florida Cancer Specialist - NorthSt. PetersburgFlorida33705-
Florida Cancer Specialist - EastWest Palm BeachFlorida33401-
Northwestern UniversityChicagoIllinois60611-
University of ChicagoChicagoIllinois60637-
Mission Cancer + Blood (Exigent Network)Des MoinesIowa50309-
Holden Comprehensive Cancer Center - University of IowaIowa CityIowa52242-
Washington University School of Medicine St. LouisSt LouisMissouri63110-
Nebraska Cancer SpecialistsOmahaNebraska68130-
Comprehensive Cancer Centers NevadaLas VegasNevada89169-
Cleveland ClinicClevelandOhio44195-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
Guthrie Medical Group, PC and Robert Packer Hospital (Guthrie Cancer Center - Sayre)SayrePennsylvania18840-
HCA Midwest HealthNashvilleTennessee60637-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Texas Oncology - West (SCRI)AbileneTexas79606-
Texas Oncology Central South (SCRI)AustinTexas78705-
Texas Oncology Northeast (SCRI)DentonTexas76201-
The University of Texas MD Anderson cancer CenterHoustonTexas77030-
Texas Oncology - Gulf Coast (SCRI)WebsterTexas77598-
American Oncology Network Vista Oncology DivisionOlympiaWashington98502-
Northwest Medical SpecialtiesTacomaWashington98405-
West Virginia University Cancer InstituteMorgantownWest Virginia26506-

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