Adult Soft Tissue Sarcoma Clinical Trials

Find Adult Soft Tissue Sarcoma Clinical Trials Near You

A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of IL-22BP/LNP Compound in Refractory Malignant Solid Tumors

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study aims to investigate the safety and efficacy of the IL-22BP/LNP compound in patients with refractory malignant solid tumors, such as advanced soft tissue sarcoma, advanced head and neck squamous cell carcinoma, and malignant melanoma, who have failed second-line treatment, have advanced recurrence or metastatic malignant solid tumors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Male or female patients: aged ≥ 18 years old and ≤ 70 years old;

• Patients with histopathologically confirmed, refractory to second-line treatment, advanced recurrent/metastatic malignant solid tumors and without standard clinical treatment regimens (such as patients with advanced soft tissue sarcoma, advanced head and neck squamous cell carcinoma, malignant melanoma, etc.);

• Eastern Cooperative Oncology Group (ECOG) performance status score: 0 - 1;

• Expected survival time ≥ 3 months;

• More than 28 days since the last chemotherapy/radiotherapy/surgery;

• More than 6 weeks since the last use of nitrosoureas or mitomycin C;

• Main organ functions are in good condition;

• Sign a written informed consent form.

Locations
Other Locations
China
West China Hospital of Sichuan University
RECRUITING
Chengdu
Contact Information
Primary
Xingchen Peng
pxx2014@163.com
18980606753
Time Frame
Start Date: 2025-01-20
Estimated Completion Date: 2026-02-20
Participants
Target number of participants: 6
Treatments
Experimental: IL-22BP/LNP compound cohort
In this study, six patients were divided into two groups (n=3 per group), which received 25 μg or 50 μg of the IL-22BP/LNP compound, respectively. The treatment will be administered by intratumoral injection. Enrolled subjects will receive inoculations of IL-22BP/LNP compound injection according to their respective dose groups, which include 5 doses for basic immunization and subsequent personalized treatment. During the basic immunization, the first 4 doses will be given at an interval of 1 week each, and the 5th dose will be administered 1 month after the 4th dose. The entire course of treatment lasts for two months.
Sponsors
Leads: Xingchen Peng

This content was sourced from clinicaltrials.gov