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Refractory Malignant Solid TumorsPhase 1NCT07040943

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

A Phase 1 study testing IL-22BP in people with Refractory Malignant Solid Tumors and mRNA Vaccine, run by West China Hospital at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 years
What is being tested?
IL-22BP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesChina
Study dates
29 Jun 2025to 20 Jul 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 12Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Department of Radiation Oncology

    Chengdu, Sichuan, 610000

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610000

Other trials in China

About this study

Official title: A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Antitumor Activity of IL - 22BP in Refractory Malignant Solid Tumors.

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

Read the detailed description

Cancer is a leading global cause of death, with advanced cases posing significant treatment challenges due to low efficacy and severe side effects. Gene therapy, especially mRNA-based immunogene therapy, offers promise. IL-22 promotes tumor progression, and its antagonist, IL-22BP, can inhibit tumor growth.

Patients with refractory, metastatic solid tumors unresponsive to second-line therapy lack viable options. This study aims to establish a novel IL-22BP-based mRNA treatment for advanced cancers.

Being tested
IL-22BP

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IL-22BPBiological

    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.

Study groups in NCT07040943
Study groupRoleWhat they receive
Treatment CohortExperimentalIn 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.
Receives: Biological: IL-22BP

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

  5. Progression - Free Survival(PFS)

    Defined as the time between first treatment with IL-22BP and first disease progression or death from any cause progression or death from any cause.

    Measured: 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.

  6. Overall Survival(OS)

    OS defined as time from first treatment with IL-22BP to death from any cause.

    Measured: From the time when the patients were enrolled in the study until six months after the last dose of the IL-22BP was injected. The time window was typically 8 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2025
  2. Study start29 Jun 2025
  3. Primary completion20 Jan 2026
  4. Study completion20 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07040943
Sponsor's protocol ID
2024 (1911)
Status last verified
Jul 2026
First submitted
19 Jun 2025
Last updated
30 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33538338

  • 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.

    PubMed 33843999

  • 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.

    PubMed 32585307

  • 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.

    PubMed 34394960

  • 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.

    PubMed 35701851

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IL-22BP in people with Refractory Malignant Solid Tumors and mRNA Vaccine, run by West China Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with DLT and Treatment-Related Adverse Event (time frame: Participation in the whole process of the study. The time window was typically 2 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07040943, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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