Clinical Trial of IL - 22BP Safety, Tolerability, and Antitumor Activity in Refractory Solid Tumors.
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorWest China Hospital
About this trial
This study aims to investigate the safety and efficacy of the IL-22BP in patients with refractory malignant solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
IL-22BP
Biological/VaccineDuring the injection of IL-22BP, there were two dose groups, namely 25 μg and 50 μg of mRNA, with three participants in each dose group, aiming to evaluate the safety and tolerability of the IL-22BP. The treatment will be administered by intratumoral injection. Enrolled subjects will receive inoculations of IL22BP injection according to their respective dose groups, which include 5 doses for basic immunization. During the basic immunization, the first 4 doses will be given at an interval of 1 week each, and the 5th dose will be inoculated 1 month after the 4th dose.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: Treatment CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with DLT and Treatment-Related Adverse Event
Evaluate the incidence of dose-limiting toxicity during the treatment with IL-22BP formulation and the treatment-related adverse reactions.
Time frame
Participation in the whole process of the study. The time window was typically 2 months.Secondary outcomes
1
Objective Response Rate
It refers to the proportion of patients whose tumors have shrunk to a certain extent and remained so for a certain period of time. It is a direct indicator to measure the anti-tumor activity of drugs.It is usually calculated as the percentage of the sum of the number of patients with complete response (CR) and partial response (PR) in the total number of patients.
Time frame
From the time when the patients were enrolled in the study until one month after the last dose of the IL-22BP was injected.The time window was typically 2 months.2
Disease Control Rate
It refers to the proportion of patients whose tumors have shrunk or remained stable. It reflects the control of tumor growth by treatment, including tumor shrinkage (as involved in ORR) and the situation where the tumor does not progress.It is calculated as the percentage of the sum of the number of patients with complete response (CR), partial response (PR), and stable disease (SD) in the total number of patients.
Time frame
From the time when the patients were enrolled in the study until one month after the last dose of the IL-22BP was injected.The time window was typically 2 months.3
Time to first complete remission, partial remission on treatment with IL-22BP preparation.
Complete Response: All target lesions disappear, no new lesions emerge, and tumor markers return to normal. This means that, from the perspective of imaging and relevant examinations, the tumor has completely vanished, and the patient's condition has achieved the most ideal improvement. For example, in the treatment of lymphoma, if enlarged lymph nodes completely disappear as detected by imaging examinations such as PET-CT, and relevant tumor markers in the blood also return to normal, it can be judged as a complete response. Partial Response: The sum of the maximum diameters of target lesions is reduced by ≥ 30%, and no new lesions appear. Taking lung cancer as an example, if the sum of the maximum diameters of lung tumors is reduced by more than 30% after treatment and no new tumor lesions are detected, it is in a partial response state. This situation indicates that the tumor responds to the treatment and the patient's condition is under a certain degree of control.
Time frame
From the time when the patients were enrolled in the study until one month after the last dose of the IL-22BP was injected.The time window was typically 2 months.4
Duration of Response
It is defined as the time between the first confirmation of complete response, partial response and the first disease progression or death from any cause.
Time frame
From the time when the patients were enrolled in the study until one month after the last dose of the IL-22BP was injected.The time window was typically 2 months.Sponsors and contacts
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Source ClinicalTrials.gov