Safety, Tolerability, and Preliminary Antitumor Activity of Cationic Peptide-IL22BP mRNA in Advanced Solid Tumors
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CP-IL22BP mRNA intratumorally injection
Biological/VaccineCP-IL22BP mRNA will be administered via intratumoral injection. A total of 5 doses will be given, with subsequent doses administered once weekly after the first injection.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Intratumoral CP-IL22BP mRNA injection groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
DLT is defined as any Treatment-Related Adverse Event (TRAE) or clinically significant laboratory abnormality occurring during the DLT observation period. TRAEs include events judged by the investigator to be "definitely," "probably," or "possibly" related to the study treatment. Severity will be graded according to NCI-CTCAE v5.0.
Time frame
From the first dose to the end of treatment at 9 weeks2
Number of participants with treatment discontinuation due to treatment-related adverse events during the first treatment cycle
Treatment-related adverse events (TRAEs) will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Treatment discontinuation is defined as permanent cessation of CP-IL22BP mRNA administration due to investigator-determined TRAEs occurring during the first treatment cycle.
Time frame
From the first dose to the end of treatment at 9 weeksSecondary outcomes
1
Objective Response
Number of participants achieving a Best Overall Response (BOR) of either Complete Response (CR) or Partial Response (PR) according to RECIST v1.1. Due to the small sample size, data will be reported as absolute counts.
Time frame
Time Frame: Up to 6 months from the date of the first dose.2
Progression-Free Survival
Progression-Free Survival (PFS) is defined as the time interval from the start of treatment until the first documented occurrence of disease progression (PD) according to RECIST v1.1, or death due to any cause, whichever occurs first.
Time frame
Up to 6 months from the date of the first dose.3
Overall Survival
OS is defined as the time interval from the start of treatment to death due to any cause. For participants who are still alive at the end of the study, data will be censored at the last known date of follow-up.
Time frame
Up to 12 months from the date of the first dose.Sponsors and contacts
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Source ClinicalTrials.gov