RecruitingmRNA VaccineSolid Tumor CancerPeptides
Safety, Tolerability, and Preliminary Antitumor Activity of Cationic Peptide-IL22BP mRNA in Advanced Solid Tumors
Eligible age
18–70 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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?
Sponsor: West China Hospital
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).
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.
Source: ClinicalTrials.gov · NCT07583654 · last updated 2026-07-14