NCT06365918

Study of VG2025 Delivered Intraperitoneally in Patients With Advanced Solid Tumors With Carcinomatosis

Phase I Study of VG2025 Delivered Intraperitoneally in Patients With Advanced Solid Tumors With Carcinomatosis

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced Solid Tumor
• Carcinomatosis

Interventions

Type	Name	Description
DRUG	VG2025	Given by Intraperitoneal

Timeline

• Start date: 2024-09-30
• Primary completion: 2024-10-02
• Completion: 2024-10-02
• First posted: 2024-04-15
• Last updated: 2025-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study