Perioperative Therapies in Locally Advanced Unresectable Gastric Cancer
Gastric cancer (GC) is the fifth most commonly diagnosed cancer, with over one million cases diagnosed annually worldwide. Human epidermal growth factor receptor 2 (HER2) overexpression in GC (seen in 4.4% to 53.4% of patients in different reports) is predictive biomarker of response to HER2-targeting therapies. Trastu
| Condition(s) | Stomach Neoplasms |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | Gastric cancer (GC) is the fifth most commonly diagnosed cancer, with over one million cases diagnosed annually worldwide. Human epidermal growth factor receptor 2 (HER2) overexpression in GC (seen in 4.4% to 53.4% of patients in different reports) is predictive biomarker of response to HER2-targeting therapies. Trastuzumab in combination with cisplatin or oxaliplatin, and a fluoropyrimidine (capecitabine or 5-fluorouracil \[5-FU\]), is approved anti-HER2 therapy for first-line treatment of HER2-positive gastric or gastroesophageal junction (GEJ) cancer. Rilvegostomig 750 mg Q3W was selected as recommended Phase 2 dose based on all available ARTEMIDE-01 clinical safety, efficacy, PK, RO data as well as modeling analysis. The dose of 750 mg Q3W is predicted to achieve intra-tumoral RO of ≥ |
| Who can participate | Inclusion Criteria: * 1\. Provision of fully informed consent prior to any study specific procedures. * 2\. Patients must be ≥ 19 years of age * 3\. Body weight \> 30kg * 4\. Has a Pathologically documented adenocarcinoma of gastric or gastroesophageal junction with HER2 IHC results. * 5\. In initial Cohort, HER2 positive (HER2 IHC 3+ or HER2 IHC 2+/ISH positive)) * 6\. Locally advanced unresectable disease by physician's discretion (ex. cT4 or bulky Nx node or localized peritoneal seeding) No evident distant organ metastasis. * 7\. ECOG performance status PS 0-1 with no deterioration between screening and the first dose of study treatment. * 8\. Has LVEF ≥ 50% by either echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan within 28 days before treatment * 9\. Has measurable target |
| Ages | 19 Years |
| Sex | All |
| Lead sponsor | Jeeyun Lee |
| Locations | Seoul, South Korea |
| Start date | 2025-01-22 |
| NCT ID | NCT06630130 |
| Official listing | https://clinicaltrials.gov/study/NCT06630130 |