Clinical Trial of IL - 22BP Safety, Tolerability, and Antitumor Activity in Refractory Solid Tumors.

NCT07040943 | Recruiting Phase 1

• 1 other identifier: 2024 (1911)
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to investigate the safety and efficacy of the IL-22BP in patients with refractory malignant solid tumors.

Conditions

mRNA Vaccine; Refractory Malignant Solid Tumors; Interleukin

Outcome Measures

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.

  Participation in the whole process of the study. The time window was typically 2 months.

Secondary Outcomes (6)

• Objective Response Rate

  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.

• Disease Control Rate

  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.

• Time to first complete remission, partial remission on treatment with IL-22BP preparation.

  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.

• Duration of Response

  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.

• Progression - Free Survival(PFS)

  From the time when the patients were enrolled in the study until three months after the last dose of the IL-22BP was injected. The time window was typically 6 months.

Study Arms (1)

Treatment Cohort

EXPERIMENTAL

In this study, three patients were grouped together. Subsequently, doses of 25 μg and 50 μg of the IL-22BP were administered to them respectively. 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.

Biological: IL-22BP

Interventions

IL-22BP BIOLOGICAL

During 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 Cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• More than 28 days since the last chemotherapy/radiotherapy/surgery;
• More than 6 weeks since the last use of nitrosoureas or mitomycin C;
• Main organ functions are in good condition;
• Sign a written informed consent form.

You may not qualify if:

• 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.
• 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.
• Those with a history of psychotropic drug abuse who are unable to quit or have mental disorders;
• 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).
• Subjects are currently receiving immunosuppressive treatment.
• Have a history of drug abuse or known medical, psychological, or social conditions, such as a history of alcoholism or drug use.
• Known to be allergic, hypersensitive, or intolerant to the studied IL-22BP (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.
• 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.
• According to the investigator's judgment, there are concomitant diseases that seriously endanger patient safety or affect the patient's completion of the study.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (2)

Department of Radiation Oncology

Chengdu, Sichuan, 610000, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

Related Publications (5)

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

• Gersten O, Barbieri M. Evaluation of the Cancer Transition Theory in the US, Select European Nations, and Japan by Investigating Mortality of Infectious- and Noninfectious-Related Cancers, 1950-2018. JAMA Netw Open. 2021 Apr 1;4(4):e215322. doi: 10.1001/jamanetworkopen.2021.5322.

  PMID: 33843999 BACKGROUND

• Kempski J, Giannou AD, Riecken K, Zhao L, Steglich B, Lucke J, Garcia-Perez L, Karstens KF, Wostemeier A, Nawrocki M, Pelczar P, Witkowski M, Nilsson S, Konczalla L, Shiri AM, Kempska J, Wahib R, Brockmann L, Huber P, Gnirck AC, Turner JE, Zazara DE, Arck PC, Stein A, Simon R, Daubmann A, Meiners J, Perez D, Strowig T, Koni P, Kruglov AA, Sauter G, Izbicki JR, Guse AH, Rosch T, Lohse AW, Flavell RA, Gagliani N, Huber S. IL22BP Mediates the Antitumor Effects of Lymphotoxin Against Colorectal Tumors in Mice and Humans. Gastroenterology. 2020 Oct;159(4):1417-1430.e3. doi: 10.1053/j.gastro.2020.06.033. Epub 2020 Jun 22.

  PMID: 32585307 BACKGROUND

• Hou X, Zaks T, Langer R, Dong Y. Lipid nanoparticles for mRNA delivery. Nat Rev Mater. 2021;6(12):1078-1094. doi: 10.1038/s41578-021-00358-0. Epub 2021 Aug 10.

  PMID: 34394960 BACKGROUND

• Kiaie SH, Majidi Zolbanin N, Ahmadi A, Bagherifar R, Valizadeh H, Kashanchi F, Jafari R. Recent advances in mRNA-LNP therapeutics: immunological and pharmacological aspects. J Nanobiotechnology. 2022 Jun 14;20(1):276. doi: 10.1186/s12951-022-01478-7.

  PMID: 35701851 BACKGROUND

MeSH Terms

Interventions

interleukin-22 receptor

Central Study Contacts

Xingchen Peng

CONTACT

18980606753; pxx2014@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 27, 2025
• Study Start: June 29, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)