A Clinical Trial Evaluating IL-22BP/LNP Compound in Refractory Malignant Solid Tumors for Safety, Tolerability and Activity

NCT07100210 | Recruiting Phase 1

• 1 other identifier: 2024-1911
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

mRNA Vaccine; Refractory Malignant Solid Tumors; Interleukin

Outcome Measures

Primary Outcomes (1)

• Incidence of Dose-Limiting Toxicities and Treatment Interruptions Due to Adverse Events During the First Cycle of IL-22BP/LNP Treatment

  Evaluate the incidence of dose-limiting toxicity (DLT) during the treatment with IL-22BP/LNP compound and the number of treatment interruptions due to treatment-related adverse reactions during the first treatment cycle.

  Participation in the whole process of the study.The entire treatment period lasts approximately 2 months.

Secondary Outcomes (7)

• Objective Response Rate(ORR)

  From the time when the patients were enrolled in the study until one month after the last dose of the IL-22BP/LNP compound was injected.The time window is approximately 2 months.

• Disease Control Rate (DCR)

  From the time when the patients were enrolled in the study until one month after the last dose of the IL-22BP/LNP compound was injected.The time window is approximately 2 months.

• Time to first complete remission (CR), partial remission (PR) on treatment with IL-22BP preparation.

  From the time when the patients were enrolled in the study until one month after the last dose of the IL-22BP/LNP compound was injected.The time window is approximately 2 months.

• Duration of Response(DOR)

  From the time when the patients were enrolled in the study until one month after the last dose of the IL-22BP/LNP compound was injected. The time window is approximately 2 months.

• Duration of first confirmed disease stabilization

  From the time when the patients were enrolled in the study until one month after the last dose of the IL-22BP/LNP compound was injected.The time window is approximately 2 months.

Study Arms (1)

IL-22BP/LNP compound cohort

EXPERIMENTAL

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.

Biological: IL-22BP mRNA vaccine injection

Interventions

IL-22BP mRNA vaccine injection BIOLOGICAL

During the injection of IL-22BP/LNP compound, 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/LNP compound formulation. 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 treatment period lasts for 2 months.

IL-22BP/LNP compound cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Have participated in other drug clinical trials within 4 weeks;
• The tumor is located close to major blood vessels or the trachea;
• Patients with uncontrolled cardiac clinical symptoms or diseases, such as heart failure of NYHA class II or above, unstable angina pectoris, having had a myocardial infarction within 1 year, and having clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention.
• For female subjects: pregnant or lactating women.
• Patients have active tuberculosis, bacterial or fungal infections (≥ grade 2 of NCI-CTCAE 5.0); have active HIV infection, active HBV infection, or HCV infection.
• Those with a history of psychotropic drug abuse who are unable to quit or have mental disorders;
• Subjects have any active autoimmune diseases or a history of autoimmune diseases (such as, but not limited to: uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or those whose asthma in childhood has been completely relieved and who do not require any intervention in adulthood can be included; subjects with asthma that requires bronchodilators for medical intervention cannot be included).
• Subjects are currently receiving immunosuppressive treatment.
• Have a history of drug abuse or known medical, psychological, or social conditions, such as a history of alcoholism or drug use.
• Known to be allergic, hypersensitive, or intolerant to the studied IL-22BP/LNP (including any excipients). Have a severe allergy history to any drugs, foods, or vaccines in the past, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local allergic necrotizing reaction (Arthus reaction), etc.
• From the screening period to 12 months after the completion of drug injection, female subjects have pregnancy plans or the partners of male subjects have pregnancy plans.
• According to the investigator's judgment, there are concomitant diseases that seriously endanger patient safety or affect the patient's completion of the study.

Sponsors & Collaborators

• Xingchen Peng: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (9)

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Study Officials

• Xingchen Peng

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingchen Peng

CONTACT

18980606753; pxx2014@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: August 3, 2025
• Study Start: January 20, 2025
• Primary Completion: February 20, 2026
• Study Completion: February 20, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)