SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT06123494
Phase
PHASE3
Status
Recruiting
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Conditions

  • HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR-A1811 — DRUG
    SHR-A1811 6.4 mg/kg IV infusion every 3 weeks on Day 1 of each 21-day cycle
  • Ramucirumab / Paclitaxel/ Docetaxel/ Irinotecan — DRUG
    Ramucirumab 8mg/kg，D 1,15 + Paclitaxel 80mg/m2，D1,8,15，Q4W; Paclitaxel 80mg/m2，D1,8,15，Q4W; Docetaxel 75mg/m2，D1，Q3W; Irinotecan 150mg/m2，D1，Q2W.

Study Details

This study will assess the efficacy and safety of SHR-A1811 compared with treatment chosen by the investigator in participants with HER2-positive (defined as immunohistochemistry \[IHC\] 3+ or IHC 2+/in situ hybridization \[ISH\]+) gastric or GEJ adenocarcinoma (based on \[American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines who have progressed on or after a first-line anti-HER2 therapy-containing regimen.

Key Dates

Start date
Jan 9, 2024
Status verified
Jan 2024
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SHR-A1811
  • Active Comparator: The investigators' choice

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Time from date of randomization until death (due to any cause), up to approximately 42 months ]

Central Contacts