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A Randomized, Double-blinded, Multicenter, Phase Ⅲ Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy (XELOX) versus Trastuzumab and Chemotherapy (XELOX) with or without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer
EU CTIS ID: 2024-516633-12-00
What this study is testing
To evaluate the efficacy of HLX22 in combination with trastuzumab + chemotherapy versus trastuzumab + chemotherapy ± pembrolizumab as first-line treatment for patients with locally advanced/metastatic gastroesophageal junction and gastric cancer.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the ICF; willing to comply with and able to complete all trial procedures.
- HIV antibody (–); if HIV antibody (+), the subject should receive antiretroviral therapy for at least four weeks and have an HIV viral load less than 400 copies/mL prior to enrollment.
- Has adequate organ function as defined in the protocol.
- Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days before randomization. Female subjects of childbearing potential and male subjects with female partners of childbearing potential have to adopt at least one highly effective contraceptive measure as defined by Clinical Trials Facilitation Group（CTFG） (such as intra-uterine contraceptive device, contraceptive pill or condom, female/male sterilization, etc.) during the study treatment period, and at least 9 months after the last dose of study treatment.
- Male or female who is at least 18 years of age or a country’s minimal age of maturity or greater 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.
You likely can't join if
- Subjects with other malignant tumors within 2 years before the randomization. Subjects with localized tumors that have been resolved, such as cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, and thyroid carcinoma, may be enrolled.
- Subjects with history or complicated interstitial lung disease, an active infection requiring systemic therapy or active tuberculosis.
- Subjects who received live vaccines within 28 days prior to randomization; except for seasonal influenza or inactivated COVID-19 vaccines.
- Subjects who had a major surgery within 28 days prior to the randomization.
- Subjects who received radical radiotherapy within 28 days prior to the randomization.
- Subjects who were participating in or had participated in a study of an investigational agent or had used an investigational device within 28 days prior to the randomization.
See the full eligibility criteria
Who can join
- Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the ICF; willing to comply with and able to complete all trial procedures.
- HIV antibody (–); if HIV antibody (+), the subject should receive antiretroviral therapy for at least four weeks and have an HIV viral load less than 400 copies/mL prior to enrollment.
- Has adequate organ function as defined in the protocol.
- Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days before randomization. Female subjects of childbearing potential and male subjects with female partners of childbearing potential have to adopt at least one highly effective contraceptive measure as defined by Clinical Trials Facilitation Group（CTFG） (such as intra-uterine contraceptive device, contraceptive pill or condom, female/male sterilization, etc.) during the study treatment period, and at least 9 months after the last dose of study treatment.
- Male or female who is at least 18 years of age or a country’s minimal age of maturity or greater 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.
- Has measurable disease as assessed by BICR according to the Response Evaluation Criteria in Solid Tumors (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.
- Hepatitis B surface antigen (HBsAg) (–) and hepatitis B core antibody (HBcAb) (–); if HBsAg (+) or HBcAb (+), hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be < 2,500 copies/mL or 500 IU/mL or within the normal range of this site (And if the site has a normal range, HBV-DNA should be within the range of the site).
- HCV antibody (–); if HCV antibody (+), HCV-RNA testing must be negative before enrollment. Subjects co-infected with hepatitis B and C will be excluded (tested positive for HBsAg or HBcAb and positive for HCV antibody).
What rules you out
- Subjects with other malignant tumors within 2 years before the randomization. Subjects with localized tumors that have been resolved, such as cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, and thyroid carcinoma, may be enrolled.
- Subjects with history or complicated interstitial lung disease, an active infection requiring systemic therapy or active tuberculosis.
- Subjects who received live vaccines within 28 days prior to randomization; except for seasonal influenza or inactivated COVID-19 vaccines.
- Subjects who had a major surgery within 28 days prior to the randomization.
- Subjects who received radical radiotherapy within 28 days prior to the randomization.
- Subjects who were participating in or had participated in a study of an investigational agent or had used an investigational device within 28 days prior to the randomization.
- Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.
- Subjects who had a known history of psychotropic drug abuse or drug addiction.
- Lactating subject.
- Known dihydropyrimidine dehydrogenase deficiency or current use of antiviral drug sorivudine or its chemically related analogs, such as brivudine.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ adenocarcinoma.. Patient may have received prior perioperative therapy (neoadjuvant or adjuvant therapy) as long as it was completed at least 6 months prior to randomization and without progression.
- Prior use of doxorubicin with in vivo concentrations > 360 mg/m2 (or equivalent) as described in the protocol.
- Previous treatment with any HER2-target therapy.
- Residual toxicity resulting from previous therapy. Alopecia is permitted.
- Active gastrointestinal bleeding (Grade ≥ 2 according to National Cancer Institute [NCI] CTCAE v5.0).
- Presence of central nervous system (CNS) metastases and/or leptomeningeal disease.
- Occurrence of cerebrovascular accidents, myocardial infarction, unstable angina and poorly controlled arrhythmia (including QTc interval ≥ 470 ms) (QTc interval calculated according to the Fridericia formula) within half a year prior to the randomization.
- According to the New York Heart Association (NYHA) classification, subjects with class III or IV cardiac insufficiency or color Doppler echocardiogram (ECHO): left ventricular ejection fraction (LVEF) < 55%.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- China
- Argentina
- Turkey
- Peru
- Chile
- Japan
- Georgia
- Korea, Republic of
- Brazil
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; China; Argentina; Turkey; Peru; Chile and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.