HLX22 + Trastuzumab + Chemotherapy for Gastric Cancer

Recruiting at 116 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments for individuals with a specific type of stomach cancer that has spread or cannot be surgically removed. It aims to determine if adding HLX22 (an experimental drug) to the standard treatment of trastuzumab and chemotherapy is safe and effective. Participants are divided into two groups: one receives HLX22 with their treatment, while the other receives a placebo (a substance with no therapeutic effect). The trial seeks participants who have not previously undergone HER2-targeted therapy and have a confirmed diagnosis of untreated HER2-positive gastric or gastroesophageal junction cancer. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that HLX22, when combined with trastuzumab and chemotherapy, is generally safe. One study found that HLX22's safety profile was similar to a placebo, with no treatment-related deaths in the HLX22 group. This indicates that HLX22 is usually well-tolerated by patients with HER2-positive gastric cancer.

Trastuzumab and chemotherapy, standard cancer treatments, are generally safe when used correctly. They have been used for many years, and doctors are familiar with their side effects. While side effects can occur, they are usually manageable with medical care.

Overall, current research suggests that combining HLX22 with trastuzumab and chemotherapy is safe and tolerable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of HLX22 with trastuzumab and chemotherapy for gastric cancer because it offers a novel approach to targeting the disease. Unlike traditional treatments that primarily focus on chemotherapy and trastuzumab alone, HLX22 is an innovative monoclonal antibody that specifically targets the HER2 protein, which is overexpressed in some gastric cancers. This targeted mechanism has the potential to enhance the efficacy of existing therapies by more precisely attacking cancer cells. Additionally, the inclusion of pembrolizumab, an immunotherapy drug, in some patients aims to boost the body's immune response against the cancer, offering a comprehensive strategy to improve outcomes.

What evidence suggests that this trial's treatments could be effective for gastric cancer?

Research shows that adding HLX22 to the treatment plan for HER2-positive stomach cancer can improve outcomes. In this trial, participants in the experimental group will receive HLX22 with trastuzumab and chemotherapy. Studies have found that this combination helps patients live longer without their cancer worsening. Updated data from earlier research also suggest it effectively manages stomach cancer. The side effects remain manageable, making it a promising option. Overall, HLX22 has the potential to enhance cancer treatment when combined with the current treatment plan. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

henlius.com

henlius.com/en/NewsDetails-5289-26.html

Henlius Unveils Updated Phase 2 Results and ...

Updated data from the HLX22-GC-201 study demonstrated that the efficacy benefit of HLX22 in HER2-positive gastric cancer remained stable with ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666634024002502

A randomized phase 2 study of HLX22 plus trastuzumab ...

The results demonstrate that adding HLX22 to HLX02 and XELOX prolongs progression-free survival and enhances antitumor response in these ...

3.

onclive.com

onclive.com/view/hlx22-receives-fda-orphan-drug-designation-in-gastric-cancer

HLX22 Receives FDA Orphan Drug Designation in Gastric ...

The FDA has granted orphan drug designation to HLX22 for the treatment of patients with gastric cancer based on positive data from the HLX22-GC-201 study.

4.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.440

HLX22 plus trastuzumab and XELOX for first-line treatment ...

Conclusions: With a manageable safety profile, the addition of HLX22 to first-line treatment with trastuzumab plus XELOX conferred survival ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11010911/

HER2-Positive Gastric Cancer and Antibody Treatment

This review aims to give an overview of the current standard-of-care treatment as well as new therapeutic approaches to targeting HER2-positive gastric cancer.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38986608/

A randomized phase 2 study of HLX22 plus trastuzumab ...

Conclusions: Adding HLX22 to HLX02 and XELOX prolonged PFS and enhanced antitumor response in the first-line treatment of HER2-positive gastric ...