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

Launched by XINGCHEN PENG · Aug 1, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called IL-22BP/LNP in people with certain types of advanced cancer that have not responded to previous treatments. These cancers include soft tissue sarcoma, head and neck cancer, and melanoma, which is a serious form of skin cancer. The main goal of the study is to see if this new treatment is safe and well-tolerated, and to learn whether it might help control the cancer in patients who have few other options.

People who may be eligible to join are adults between 18 and 70 years old who have advanced cancer that has come back or spread and who have already tried at least two other treatments without success. Participants need to be in generally good health aside from their cancer, able to carry out daily activities, and expected to live at least three more months. The study is not yet open for enrolling patients, and those interested will need to give informed consent before joining. It’s also important to know that certain health conditions, infections, or pregnancy will exclude someone from participating. If you or a loved one fits this description and are interested, this trial could offer a new option to explore with your doctor.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.
• • 9. Have a history of drug abuse or known medical, psychological, or social conditions, such as a history of alcoholism or drug use.
• • 10. 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.
• • 11. 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.
• • 12. According to the investigator's judgment, there are concomitant diseases that seriously endanger patient safety or affect the patient's completion of the study.