IL-22BP mRNA vaccine for refractory advanced solid tumors

A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of IL-22BP/LNP Compound in Refractory Malignant Solid Tumors

This trial will test an IL-22BP mRNA vaccine in lipid nanoparticles to see if it is safe and can slow or shrink advanced solid tumors in adults who have failed standard second-line treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: West China Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT07100210 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional trial at West China Hospital administers an IL-22BP mRNA vaccine formulated in lipid nanoparticles to adults with refractory recurrent or metastatic solid tumors. The primary goal is to characterize safety and tolerability, with secondary assessments of preliminary anti-tumor activity and immune response. Eligible participants are 18–70 years old with ECOG 0–1, adequate organ function, and specified washout periods from prior therapies. The vaccine is given by injection and participants will be closely monitored for adverse events, lab changes, and tumor response.

Who should consider this trial

Good fit: Adults aged 18–70 with histologically confirmed advanced recurrent or metastatic solid tumors refractory to second-line therapy, ECOG 0–1, adequate organ function, and willingness to attend the study center are ideal candidates.

Not a fit: Patients with tumors very close to major blood vessels or the trachea, uncontrolled cardiac disease, recent participation in other investigational drug trials, or poor performance status are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, the IL-22BP mRNA vaccine could stimulate anti-tumor immunity and slow tumor growth in patients with few remaining treatment options.

How similar studies have performed: mRNA vaccine platforms have shown success for infectious diseases and early promise in cancer immunotherapy, but an IL-22BP-targeted mRNA vaccine is novel and has little to no prior clinical data.

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.

Where this trial is running

Chengdu, Sichuan

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Principal investigator: Xingchen Peng — West China Hospital
• Study coordinator: Xingchen Peng

Conditions: Refractory Malignant Solid Tumors, mRNA Vaccine, Interleukin