Advanced Solid Tumor Clinical Trial
Official title:
Phase I Study of VG2025 Delivered Intraperitoneally in Patients With Advanced Solid Tumors With Carcinomatosis
To find the recommended dose of the investigational drug VG2025 that can be given intraperitoneally (given directly into the abdominal cavity) to participants with advanced solid tumors.
Primary Objectives 1. To assess safety and tolerability of VG2025 following IP administration 2. To determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of IP VG2025 Secondary Objectives 1. To estimate progression free survival 2. To characterize the biodistribution or shedding profile of detectable VG2025 DNA in tumor (biopsy samples), IP fluid, and blood 3. To evaluate IL-12, IL-15, and other cytokine levels in tumor (biopsy samples), IP fluid, and blood 4. To evaluate tumor CEA expression 5. To evaluate the objective response rate (ORR) and clinical benefit rate (CBR) of IP administration of VG2025 in the overall patient population and by dose level 6. To characterize changes in the IP and tumor immune microenvironment in response to treatment 7. To correlate circulating tumor DNA (ctDNA) with disease status ;
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