RecruitingPhase 2Phase 3NCT06504732

To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Gastric Cancer

A Phase II/III Clinical Study Evaluating IAH0968 in Combination or Not in Combination With the CAPEOX Regimen in HER2-expressing Advanced/Metastatic Solid Tumors and Gastric Cancer

Sponsor

SUNHO（China）BioPharmaceutical CO., Ltd.

Enrollment

574 participants

Start Date

Aug 15, 2024

Study Type

INTERVENTIONAL

Conditions

Stomach Neoplasms Solid Tumor

Summary

The safety, tolerability, and determination of the maximum tolerated dose (MTD) of the combination therapy were first evaluated for IAH0968 in combination with or without the CAPEOX regimen in unsystematically treated subjects with HER2-expressing advanced/metastatic colorectal or gastric cancers (including adenocarcinomas of the gastro-esophageal junction) or HER2-hypo-expressing advanced/metastatic solid tumors. The efficacy of IAH0968 in combination with the CAPEOX regimen versus trastuzumab in combination with the CAPEOX regimen in subjects with HER2-positive advanced/metastatic gastric cancer, including gastro-esophageal junction adenocarcinoma, was then assessed by progression-free survival (PFS) and OS according to the Research and Evaluation Criteria for the Evaluation of Efficacy in Solid Tumors (RECIST) 1.1.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called IAH0968 combined with a chemotherapy regimen (CAPEOX: capecitabine and oxaliplatin) for patients with HER2-positive stomach cancer. HER2-positive means the cancer cells have too many copies of a protein that makes them grow faster. The study aims to find the right dose and see how effective this combination is. **You may be eligible if...** - You are 18–75 years old with confirmed HER2-positive advanced or metastatic gastric or gastroesophageal junction cancer - You have not yet received systemic treatment for your advanced cancer (previous adjuvant chemotherapy ended more than 6 months ago) - You are in reasonably good physical condition - You have measurable tumors that can be assessed on scans **You may NOT be eligible if...** - You have already been treated with systemic therapy for advanced disease - You are not HER2-positive (as confirmed by testing) - You have serious uncontrolled medical 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

DRUGIAH0968

Experimental：IAH0968 15 mg/kg on Day 1 of each 3-week cycle as an IV infusion. Drug: Oxaliplatin 130 mg/m\^2 on Day 1 of each 3-week cycle over 2 hours as an IV infusion, administered as part of CAPOX chemotherapy regimen. Drug: Capecitabine 1000 mg/m\^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of CAPOX chemotherapy regimen.

DRUGTrastuzumab Injection

Active Comparator: Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance dose administered IV on day 1 of each 3-week cycle. Drug: Oxaliplatin 130 mg/m\^2 on Day 1 of each 3-week cycle over 2 hours as an IV infusion, administered as part of CAPOX chemotherapy regimen. Drug: Capecitabine 1000 mg/m\^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of CAPOX chemotherapy regimen.