RecruitingRefractory Malignant Solid TumorsmRNA VaccineInterleukin

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

Eligible age

18–70 yrs

Accepts

All genders

Locations

0 states

Healthy volunteers

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

Sponsor: West China Hospital

✓ 1. Male or female patients: aged ≥ 18 years old and ≤ 70 years old;
✓ 2. 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.);
✓ 3. Eastern Cooperative Oncology Group (ECOG) performance status score: 0 - 1;
✓ 4. Expected survival time ≥ 3 months;
✓ 5. More than 28 days since the last chemotherapy/radiotherapy/surgery;
✓ 6. More than 6 weeks since the last use of nitrosoureas or mitomycin C;
✓ 7. Main organ functions are in good condition;
✓ 8. Sign a written informed consent form.

✕ 1. Have participated in other drug clinical trials within 4 weeks;
✕ 2. The tumor is located close to major blood vessels or the trachea;
✕ 3. 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.
✕ 4. For female subjects: pregnant or lactating women.
✕ 5. 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.
✕ 6. Those with a history of psychotropic drug abuse who are unable to quit or have mental disorders;
✕ 7. 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).
✕ 8. Subjects are currently receiving immunosuppressive treatment.

Source: ClinicalTrials.gov · NCT07040943 · last updated 2026-04-13