NCT04908813

Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer

A Randomized, Double-blinded，Multicenter，Phase II Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Placebo in Combination With Trastuzumab and Chemotherapy (XELOX) for Treatment of Locally Advanced or Metastatic Gastric Cancer (GC)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the clinical efficacy and safety of HLX22 in the HER2+ Locally Adanved or Metastatic Gastric Cancer as the first-line therapy.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria. The enrolled subjects will receive an intravenous infusion of HLX22/placebo and SOC(standard of care: Trastuzumab + XELOX) once every 3 weeks until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent or other reasons as specified in the protocol(whichever occurs earlier).

Detailed description

HLX22(25mg/kg) or HLX22(15mg/kg) or placebo will be administered intravenously \[IV\] on day 1 of each 3-week cycle. Trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance dose) will be administered IV on day 1 of each 3-week cycle. SOC chemotherapy is XELOX (1000 mg/m\^2 capecitabine administered orally twice daily \[BID\] on days 1-14 of each 3-week cycle and 130 mg/m\^2 oxaliplatin administered IV on Day 1 of each 3-week cycle).

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	HLX22	IV Q3W D1
DRUG	Placebo	IV Q3W D1
DRUG	Trastuzumab	IV Q3W D1
DRUG	Oxaliplatin	IV Q3W D1
DRUG	Capecitabine	PO Q3W D1-D14

Timeline

• Start date: 2021-09-29
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2021-06-01
• Last updated: 2024-04-15

Locations

1 site across 1 country: China