Safety, Tolerability, and Preliminary Antitumor Activity of Cationic Peptide-IL22BP mRNA in Advanced Solid Tumors

NCT07583654 | Not Yet Recruiting Phase 1

• 1 other identifier: 2026-520
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this phase 1 clinical trial is to evaluate the safety, tolerability, and preliminary antitumor activity of a peptide-delivered IL-22BP biotherapy in patients with advanced solid tumors. The main questions it aims to answer are: Is the IL-22BP formulation safe and tolerable? Does the IL-22BP formulation show preliminary antitumor activity?

Conditions

mRNA Vaccine; Solid Tumor Cancer; Peptides; Cancer Metastatic

Keywords

mRNA vaccine; Cancer metastasis; Solid tumor; IL-22

Outcome Measures

Primary Outcomes (2)

• Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

  DLT is defined as any Treatment-Related Adverse Event (TRAE) or clinically significant laboratory abnormality occurring during the DLT observation period. TRAEs include events judged by the investigator to be "definitely," "probably," or "possibly" related to the study treatment. Severity will be graded according to NCI-CTCAE v5.0.

  From the first dose to the end of treatment at 9 weeks

• Number of participants with treatment discontinuation due to treatment-related adverse events during the first treatment cycle

  Treatment-related adverse events (TRAEs) will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Treatment discontinuation is defined as permanent cessation of CP-IL22BP mRNA administration due to investigator-determined TRAEs occurring during the first treatment cycle.

  From the first dose to the end of treatment at 9 weeks

Secondary Outcomes (3)

• Objective Response

  Time Frame: Up to 6 months from the date of the first dose.

• Progression-Free Survival

  Up to 6 months from the date of the first dose.

• Overall Survival

  Up to 12 months from the date of the first dose.

Study Arms (1)

Intratumoral CP-IL22BP mRNA injection group

EXPERIMENTAL

Biological: CP-IL22BP mRNA intratumorally injection

Interventions

CP-IL22BP mRNA intratumorally injection BIOLOGICAL

CP-IL22BP mRNA will be administered via intratumoral injection. A total of 5 doses will be given, with subsequent doses administered once weekly after the first injection.

Intratumoral CP-IL22BP mRNA injection group

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 and ≤70 years.
• Histopathologically confirmed advanced recurrent/metastatic malignant solid tumors that are refractory to second-line treatment and have no available standard clinical therapeutic options (e.g., advanced soft tissue sarcoma, advanced head and neck squamous cell carcinoma, malignant melanoma, etc.).
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Expected overall survival ≥3 months.
• Interval from the last chemotherapy, radiotherapy, or surgery ≥28 days.
• Interval from the last use of nitrosourea or mitomycin C ≥6 weeks.
• Adequate organ function, defined by the following laboratory parameters within 14 days prior to enrollment:
• Hemoglobin ≥90 g/L (no blood transfusion within 14 days).
• Absolute neutrophil count \>1.5 × 10⁹/L.
• Platelet count ≥80 × 10⁹/L.
• Total bilirubin ≤1.5 × upper limit of normal (ULN).
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5 × ULN (≤5 × -ULN in case of liver metastasis).
• Creatinine clearance ≥60 mL/min (calculated by Cockcroft-Gault formula).
• Left ventricular ejection fraction (LVEF) ≥50%.
• Signed written informed consent.

You may not qualify if:

• Participation in another investigational drug clinical trial within 4 weeks.
• Tumor located adjacent to major blood vessels or trachea.
• Uncontrolled cardiac clinical symptoms or diseases, including New York Heart Association (NYHA) Class ≥2 heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant supraventricular/ventricular arrhythmias requiring treatment or intervention.
• Female patients who are pregnant or lactating.
• Active pulmonary tuberculosis, bacterial or fungal infection (≥Grade 2 per NCI-CTCAE version 5.0), active human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection.
• History of uncontrollable psychoactive substance abuse or presence of mental disorders.
• Any active autoimmune disease or history of autoimmune disease, including but not limited to uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism.
• Subjects with vitiligo or childhood asthma in complete remission (no adult intervention required) are eligible; subjects with asthma requiring bronchodilator therapy are excluded.
• Receiving immunosuppressive therapy.
• History of drug abuse or known medical, psychological, or social conditions that interfere with study compliance (e.g., alcoholism or illicit drug addiction).
• Known hypersensitivity, allergy, or intolerance to the study drug CPIL22BP mRNA (including any excipients), or history of severe allergic reactions to any drugs, foods, or vaccines (e.g., anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local Arthus reaction, etc.).
• Female subjects planning pregnancy, or male subjects whose partner plans pregnancy, from screening until 12 months after the last study drug injection.
• Any concomitant disease that, in the investigator's judgment, may seriously compromise patient safety or prevent the subject from completing the study.

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share