Safety and Tolerability of NCP-IL-22BP mRNA in Advanced Solid Tumors

May 6, 2026 updated by: Xingchen Peng, West China Hospital

A Phase I, Open-Label, Single-Arm Study to Evaluate the Safety, Tolerability, and Preliminary Anti-Tumor Activity of Non-Cationic Peptide-IL-22BP mRNA (NCP-IL-22BP mRNA) in Patients With Advanced Malignant Solid Tumors

This is a phase I, open-label, single-arm, single-center, dose-escalation study to evaluate the safety, tolerability, and preliminary anti-tumor activity of NCP-IL-22BP mRNA, a non-cationic peptide-delivered mRNA encoding interleukin-22 binding protein (IL-22BP), administered by intratumoral injection in patients with advanced malignant solid tumors who have failed second-line therapy. The study employs a classical "3+3" dose-escalation design with three dose levels (25 μg, 50 μg, and 100 μg mRNA). Each subject will receive 5 doses at weekly intervals. The primary objective is to assess the safety and tolerability of NCP-IL-22BP mRNA, and the secondary objective is to evaluate its preliminary anti-tumor activity.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • West China Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female patients aged ≥18 and ≤70 years
  2. Histopathologically confirmed advanced recurrent/metastatic malignant solid tumors that have failed second-line therapy with no standard treatment options available (e.g., advanced soft tissue sarcoma, head and neck squamous cell carcinoma, malignant melanoma)
  3. ECOG Performance Status score: 0-1
  4. Estimated life expectancy ≥3 months
  5. At least 28 days since prior chemotherapy, radiotherapy, or surgery
  6. At least 6 weeks since prior use of nitrosoureas or mitomycin C

  7. Adequate organ function within 14 days prior to enrollment:

    • Hemoglobin ≥90 g/L (no blood transfusion within 14 days)
    • Absolute neutrophil count >1.5×10⁹/L
    • Platelet count ≥80×10⁹/L
    • Total bilirubin ≤1.5×ULN
    • ALT or AST ≤2.5×ULN (≤5×ULN if liver metastases present)
    • Creatinine clearance ≥60 mL/min (Cockcroft-Gault formula)
    • Left ventricular ejection fraction (LVEF) ≥50%
  8. Signed written informed consent

Exclusion Criteria:

  1. Participation in another clinical drug trial within 4 weeks
  2. Tumor located adjacent to major blood vessels or trachea
  3. Poorly controlled cardiac conditions: NYHA class >2 heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmias requiring treatment
  4. Pregnant or breastfeeding women
  5. Active pulmonary tuberculosis, bacterial or fungal infection (≥Grade 2 per NCI-CTCAE v5.0); HIV infection, active HBV or HCV infection
  6. History of psychotropic substance abuse that cannot be discontinued, or mental disorders
  7. Active autoimmune disease or history of autoimmune disease (exceptions: vitiligo; childhood asthma in complete remission)
  8. Currently receiving immunosuppressive therapy
  9. History of drug abuse or known medical, psychological, or social conditions (e.g., alcoholism, drug addiction)
  10. Known allergy, hypersensitivity, or intolerance to IL-22BP or any excipient; history of severe allergic reactions to any drug, food, or vaccine
  11. Female subjects with pregnancy plans or male subjects whose partners have pregnancy plans from screening through 12 months after the last dose
  12. Any serious concomitant disease that, in the investigator's judgment, would jeopardize patient safety or ability to complete the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NCP-IL-22BP mRNA Dose Level 1 (25 μg)
Biological: 25 μg NCP-IL-22BP mRNA
NCP-IL-22BP mRNA administered by intratumoral injection, 5 doses at weekly intervals
Experimental: NCP-IL-22BP mRNA Dose Level 2 (50 μg)
Biological: 50 μg NCP-IL-22BP mRNA
NCP-IL-22BP mRNA administered by intratumoral injection, 5 doses at weekly intervals
Experimental: NCP-IL-22BP mRNA Dose Level 3 (100 μg)
Biological: 100 μg NCP-IL-22BP mRNA
NCP-IL-22BP mRNA administered by intratumoral injection, 5 doses at weekly intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Dose-Limiting Toxicities
Time Frame: From the first dose to 3 weeks post-dose. (approximately 3 weeks)
Number and percentage of subjects experiencing DLT during the first treatment cycle (from first dose through 7 days after the fifth dose), assessed per CTCAE v5.0
From the first dose to 3 weeks post-dose. (approximately 3 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first complete remission, partial remission on treatment with IL-22BP preparation.
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.

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.
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
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.
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.
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.
Objective Response Rate (ORR)
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.
Proportion of subjects achieving complete response (CR) or partial response (PR) per RECIST v1.1
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
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.
Proportion of subjects achieving CR, PR, or stable disease (SD) per RECIST v1.1
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.

Other Outcome Measures

Outcome Measure
Time Frame
Changes in Peripheral Blood Immune Biomarkers
Time Frame: Baseline through end of treatment (approximately 2 months)
Baseline through end of treatment (approximately 2 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Investigators

  • Principal Investigator: Xingchen Peng, The West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 28, 2026

Primary Completion (Estimated)

April 28, 2027

Study Completion (Estimated)

December 28, 2027

Study Registration Dates

First Submitted

April 24, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026(936)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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