NCT07040943

Clinical Trial of IL - 22BP Safety, Tolerability, and Antitumor Activity in Refractory Solid Tumors.

A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Antitumor Activity of IL - 22BP in Refractory Malignant Solid Tumors.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the safety and efficacy of the IL-22BP in patients with refractory malignant solid tumors.

Detailed description

Cancer is a leading global cause of death, with advanced cases posing significant treatment challenges due to low efficacy and severe side effects. Gene therapy, especially mRNA-based immunogene therapy, offers promise. IL-22 promotes tumor progression, and its antagonist, IL-22BP, can inhibit tumor growth. Patients with refractory, metastatic solid tumors unresponsive to second-line therapy lack viable options. This study aims to establish a novel IL-22BP-based mRNA treatment for advanced cancers.

Conditions

• Refractory Malignant Solid Tumors
• mRNA Vaccine
• Interleukin

Interventions

Type	Name	Description
BIOLOGICAL	IL-22BP	During the injection of IL-22BP, there were two dose groups, namely 25 μg and 50 μg of mRNA, with three participants in each dose group, aiming to evaluate the safety and tolerability of the IL-22BP. The treatment will be administered by intratumoral injection. Enrolled subjects will receive inoculations of IL22BP injection according to their respective dose groups, which include 5 doses for basic immunization. During the basic immunization, the first 4 doses will be given at an interval of 1 week each, and the 5th dose will be inoculated 1 month after the 4th dose.

Timeline

• Start date: 2025-06-29
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-06-27
• Last updated: 2026-04-13

Locations

2 sites across 1 country: China