Safety, Tolerability, and Preliminary Antitumor Activity of Cationic Peptide-IL22BP mRNA in Advanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorWest China Hospital
About this trial
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?
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CP-IL22BP mRNA intratumorally injection
Treatment groups
18 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov