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

Launched by SHANGHAI HENLIUS BIOTECH · Jul 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with HER2-positive gastric cancer or gastroesophageal junction cancer. The treatment combines a drug called HLX22 with trastuzumab and chemotherapy. The goal is to see how effective and safe this combination is for patients who have advanced or spreading cancer that has not been treated before. The study is taking place in multiple locations and will randomly assign participants to one of two groups to compare the effects of the treatment.

To participate, individuals must be at least 18 years old and have a confirmed diagnosis of locally advanced or metastatic HER2-positive gastric or gastroesophageal junction cancer. They should also have measurable disease and good overall health. Participants will receive the study treatment until it no longer benefits them, they experience unacceptable side effects, or they decide to leave the study. This trial is currently looking for volunteers, and it's important for potential participants to understand that they will be closely monitored throughout the study for their health and safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male/female who are at least 18 years of age on the day of signing the informed consent.
• • 2. With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
• • 3. Had measurable disease as assessed by IRRC according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
• • 4. 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.
• • 5. ECOG PS within 7 days before randomization: 0-1.
• • 6. Expected survival ≥ 6 months.
• • 7. Had adequate organ function
• Exclusion Criteria:
• • 1. Patients with other malignant tumors within 2 years before the randomization.
• • 2. Evidence of disease progression within 6 months (before randomization) after completion of prior neoadjuvant or adjuvant chemotherapy (or both) or radiotherapy for gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
• • 3. Previous treatment with any HER2-target therapy.
• • 4. Active gastrointestinal bleeding
• • 5. Presence of central nervous system (CNS) metastases.
• • 6. Left ventricular ejection fraction (LVEF) \< 55%.
• • 7. Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.