Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT06365918
Brief Summary:
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.
Detailed Description:
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
Study:
NCT06365918
Study Brief:
Protocol Section:
NCT06365918