RecruitingPhase 1Phase 2NCT06650332

Cadonilimab Combination Regimen as First-line Treatment for HER2-expressing GC/GEJ Patients

An Open-label, Multicohort Phase I/II Study of the Cadonilimab (AK104) Combination Regimen as First-line Treatment for HER2-expressing, Unresectable Locally Advanced or Metastatic Gastric (G) or Gastroesophageal Junction (GEJ) Cancer

Sponsor

Zhejiang Cancer Hospital

Enrollment

90 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic HER2 Positive Gastroesophageal Junction Cancer

Summary

This trial is An open-label, multicohort, multicenter clinical study aimed at evaluating the efficacy and safety of the cadonilimab combination regimen in the treatment of advanced HER-2 positive gastric/gastroesophageal junction tumors

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of cadonilimab (an immunotherapy drug) with chemotherapy and trastuzumab (a targeted drug for HER2-positive cancers) as the first treatment for people with advanced HER2-expressing stomach or gastroesophageal junction cancer. **You may be eligible if...** - You are 18–75 years old - You have confirmed advanced or metastatic stomach or gastroesophageal junction cancer - Your tumor is HER2-positive (IHC 3+ or IHC 2+ with positive gene testing) - You have not yet received chemotherapy for advanced disease - Your PD-L1 expression status has been confirmed **You may NOT be eligible if...** - You have already received chemotherapy for your advanced cancer - Your overall health is too poor for combination therapy - You have uncontrolled serious infections or autoimmune conditions - You are pregnant or breastfeeding 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

DRUGcadonilimab

Cohort 1:10 mg/kg, iv, Q3W, D1; Cohort 2/3:6 mg/kg, iv, Q2W, D1

DRUGTrastuzumab

loading dose 8 mg/kg, iv, Q3W, D1; maintenance dose 6 mg/kg, iv, Q3W, D1

DRUGXELOX

Oxaliplatin: 130 mg/m\\(\^2\\), IV, D1; Capecitabine: 1000 mg/m\\(\^2\\), oral (PO), twice daily, D1-14.

DRUGDisitamab Vedotin

1.5、2.0、2.5mg/kg，IV，D1，Q2W

DRUGmFOLFOX6

Oxaliplatin 85 mg/m\\(\^2\\), IV, d1; Leucovorin (folinic acid) 400 mg/m\\(\^2\\), IV, d1; 5-FU 400 mg/m\\(\^2\\), IV, d1, followed by 2400 mg/m\\(\^2\\), continuous intravenous infusion over 46 hours.

Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT06650332