RecruitingPhase 3NCT06123494

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

A Phase 3, Multicenter, Randomized, Open-label Study of SHR-A1811 (HER2-ADC) Compared With the Chemotherapy Treatment Chosen by the Investigators for Subjects With HER2-positive Metastatic and/or Unresectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma Who Have Progressed on or After First-line Anti-HER2 Therapy-containing Regimen


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

360 participants

Start Date

Jan 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called SHR-A1811 (an antibody-drug conjugate that targets the HER2 protein) in people with HER2-positive stomach or gastroesophageal junction cancer that has progressed after first-line treatment including a HER2-targeted therapy. **You may be eligible if...** - You are 18–75 years old with confirmed stomach or gastroesophageal junction adenocarcinoma - Your tumor tests strongly positive for HER2 (IHC 3+ or IHC 2+ with confirmed HER2 gene amplification) - Your cancer progressed during or after your first standard treatment that included a HER2-targeted drug - You are in good overall health (ECOG 0 or 1) with a life expectancy of at least 12 weeks - You have at least one measurable lesion on imaging **You may NOT be eligible if...** - Your cancer has spread to the brain and is actively causing symptoms - You have active hepatitis B (detectable HBV DNA above 500 IU/mL) or hepatitis C - You have a history of immunodeficiency or HIV - You have uncontrolled fluid accumulation around the lungs or heart - You received cancer treatment within 4 weeks before starting the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-A1811

SHR-A1811 6.4 mg/kg IV infusion every 3 weeks on Day 1 of each 21-day cycle

DRUGRamucirumab / Paclitaxel/ Docetaxel/ Irinotecan

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.


Locations(1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

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NCT06123494