HLX22 + Trastuzumab + Chemotherapy for Gastric Cancer

Recruiting at 63 trial locations

Overseen By Ying Li

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Shanghai Henlius Biotech

Must not be taking: HER2-target therapy

Disqualifiers: Other tumors, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: Up to 5 years

550 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for adults with previously untreated, advanced HER2-positive gastric or gastroesophageal junction cancer that can't be surgically removed. Participants must have measurable disease, an ECOG performance status of 0-1 (meaning they are fully active or restricted in physically strenuous activity but ambulatory), a life expectancy over 6 months, and adequate organ function.

Inclusion Criteria

My doctor expects me to live 6 months or more.

My cancer is HER2-positive and has spread beyond where it started in my stomach or gastroesophageal junction.

I am fully active or can carry out light work.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HLX22 in combination with trastuzumab and chemotherapy (XELOX) or placebo, administered once every 3 weeks until loss of clinical benefit or other specified reasons

Up to 5 years

Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Treatment Details

Interventions

• Capecitabine
• HLX22
• Oxaliplatin
• Pembrolizumab
• Trastuzumab

Trial Overview The study tests HLX22 combined with trastuzumab and chemotherapy as a first-line treatment. Patients will be randomly assigned to two groups to compare the effectiveness and safety of this combination therapy against another regimen in patients with advanced stomach cancers.

Participant Groups

Group I: Experimental group Experimental Treatment 4 Interventions

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)

Group II: Control group Active Control 4 Interventions

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

Who Is Running the Clinical Trial?

Shanghai Henlius Biotech

Lead Sponsor

Trials

100

Recruited

19,200+

Dr. Jason Zhu

Shanghai Henlius Biotech

Chief Executive Officer since 2023

MBA from Yale University

Dr. Jun Zhu

Shanghai Henlius Biotech

Chief Medical Officer

MD from an unspecified institution

Henlius USA

Collaborator

Trials

1

Recruited

550+