A Clinical Trial Evaluating IL-22BP/LNP Compound in Refractory Malignant Solid Tumors for Safety, Tolerability and Activity
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorXingchen Peng
About this trial
This study aims to investigate the safety and efficacy of the IL-22BP/LNP compound in patients with refractory malignant solid tumors, such as advanced soft tissue sarcoma, advanced head and neck squamous cell carcinoma, and malignant melanoma, who have failed second-line treatment, have advanced recurrence or metastatic malignant solid tumors.
Eligibility criteria
Qualifiers
Male or female patients: aged ≥ 18 years old and ≤ 70 years old;
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.);
Eastern Cooperative Oncology Group (ECOG) performance status score: 0 - 1;
Expected survival time ≥ 3 months;
Disqualifiers
Have participated in other drug clinical trials within 4 weeks;
The tumor is located close to major blood vessels or the trachea;
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.
For female subjects: pregnant or lactating women.
Trial design
Treatments tested in this trial
- IL-22BP mRNA vaccine injection
Treatment groups
6 Participants
are divided into 1 treatment groupSponsors and collaborators
Xingchen Peng
Lead sponsor
West China Hospital
Sponsor institution
Source ClinicalTrials.gov