A Phase 3 Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer

JRCT ID: jRCT2041240152

Registered date:18/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: HER2-positive locally advanced/metastatic adenocarcinoma of the gastric / gastroesophageal junction
• Date of first enrollment: 27/12/2024
• Target sample size: 55
• Countries of recruitment: China,Japan,South Korea,Japan,Australia,Japan,Argentina,Japan,Brazil,Japan,Chile,Japan,Peru,Japan,USA,Japan,Romania,Japan,Poland,Japan,Italy,Japan,Spain,Japan,Germany,Japan,Georgia,Japan,Turkey,Japan
• Study type: Interventional

Intervention(s)

Experimental group
- HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX)
- HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) + placebo (for pembrolizumab)
Control group
- Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX)
- Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) + pembrolizumab

Outcome(s)

Primary Outcome

- PFS per RECIST 1.1 assessed by IRRC (Independent Radiology Review Committee)
- OS

Secondary Outcome

- PFS per RECIST 1.1 assessed by investigator
- ORR assessed by IRRC and investigator per RECIST v1.1
- Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Male/female who are at least 18 years of age 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.
- Had measurable disease as assessed by Independent Radiology Review Committee (IRRC) according to the 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.
- Had adequate organ function.

Exclude criteria

- Patients with other malignant tumors within 2 years before the randomization.
- 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.
- Previous treatment with any HER2-target therapy.
- Active gastrointestinal bleeding.
- Presence of central nervous system (CNS) metastases.
- Left ventricular ejection fraction (LVEF) < 55%.
- Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.

Related Information

• Primary Sponsor: Misaki Masako
• Secondary ID(s): NCT06532006