mRNA VaccinePhase 1NCT07583654
Safety, Tolerability, and Preliminary Antitumor Activity of Cationic Peptide-IL22BP mRNA in Advanced Solid Tumors
A Phase 1 study testing CP-IL22BP mRNA intratumorally injection in people with mRNA Vaccine and Solid Tumor Cancer, run by West China Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- mRNA Vaccine, Solid Tumor Cancer, Peptides
- What is being tested?
- CP-IL22BP mRNA intratumorally injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2026to 30 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 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.
- Interval from the last chemotherapy, radiotherapy, or surgery ≥28 days.
- Interval from the last use of nitrosourea or mitomycin C ≥6 weeks.
Show all 15Show fewer
- Adequate organ function, defined by the following laboratory parameters 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 × upper limit of normal (ULN).
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5 × ULN (≤5 × -ULN in case of liver metastasis).
- Creatinine clearance ≥60 mL/min (calculated by Cockcroft-Gault formula).
- Left ventricular ejection fraction (LVEF) ≥50%.
- Signed written informed consent.
Who cannot join
- 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.
- Active pulmonary tuberculosis, bacterial or fungal infection (≥Grade 2 per NCI-CTCAE version 5.0), active human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection.
- History of uncontrollable psychoactive substance abuse or presence of mental disorders.
Show all 13Show fewer
- Any active autoimmune disease or history of autoimmune disease, including but not limited to uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism.
- Subjects with vitiligo or childhood asthma in complete remission (no adult intervention required) are eligible; subjects with asthma requiring bronchodilator therapy are excluded.
- Receiving immunosuppressive therapy.
- History of drug abuse or known medical, psychological, or social conditions that interfere with study compliance (e.g., alcoholism or illicit drug addiction).
- Known hypersensitivity, allergy, or intolerance to the study drug CPIL22BP mRNA (including any excipients), or history of severe allergic reactions to any drugs, foods, or vaccines (e.g., anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local Arthus reaction, etc.).
- Female subjects planning pregnancy, or male subjects whose partner plans pregnancy, from screening until 12 months after the last study drug injection.
- Any concomitant disease that, in the investigator's judgment, may seriously compromise patient safety or prevent the subject from completing the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Yu YM Min, M.D., 86+02885422114, 13108175138@163.com
About this study
Official title: A Clinical Trial of Cationic Peptide-IL22BP mRNA for Safety, Tolerability, and Preliminary Antitumor Activity in Patients With Advanced Malignant Solid Tumors
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?
Read the detailed description
This is a phase 1, single-arm, open-label, dose-escalation clinical trial designed to evaluate a peptide-based IL-22BP mRNA gene therapy in patients with refractory advanced malignant solid tumors. The investigational product uses a peptide delivery platform composed of natural amino acids, which is intended to improve biocompatibility, reduce toxicity, simplify manufacturing, and avoid key patent limitations associated with conventional lipid nanoparticle (LNP) systems. Unlike a traditional tumor vaccine, this intervention is designed as a targeted gene therapy that promotes intratumoral expression of IL-22BP protein to inhibit tumor progression. Preclinical toxicology studies of the peptide-mRNA complex have shown an acceptable safety profile, with no notable abnormalities in hematological or biochemical parameters. The study will use a standard "3+3" dose-escalation design to assess three fixed mRNA dose levels. The primary objective is to characterize the safety and tolerability of the IL-22BP gene formulation, and the secondary objective is to evaluate its preliminary antitumor activity.
- Conditions
- mRNA Vaccine, Solid Tumor Cancer, Peptides, Cancer Metastatic
- Being tested
- CP-IL22BP mRNA intratumorally injection
- Keywords
- mRNA vaccine, Cancer metastasis, Solid tumor, IL-22
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-IL22BP mRNA intratumorally injectionBiological
CP-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.
| Study group | Role | What they receive |
|---|---|---|
| Intratumoral CP-IL22BP mRNA injection group | Experimental | Not described Receives: Biological: CP-IL22BP mRNA intratumorally injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the first dose to the end of treatment at 9 weeks
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.
Measured: From the first dose to the end of treatment at 9 weeks
Secondary outcomes (3)
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.
Measured: Time Frame: Up to 6 months from the date of the first dose.
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.
Measured: Up to 6 months from the date of the first dose.
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.
Measured: Up to 12 months from the date of the first dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start13 Jul 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for mRNA VaccineStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583654
- Sponsor's protocol ID
- 2026-520
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Cationic Peptide-IL22BP mRNA for Safety, Tolerability, and Preliminary Antitumor Activity in Patients With Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07583654
- Acronym / sponsor ID
- 2026-520
- Conditions
- mRNA Vaccine, Solid Tumor Cancer, Peptides, Cancer Metastatic
- Keywords
- mRNA vaccine, Cancer metastasis, Solid tumor, IL-22
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
This is a phase 1, single-arm, open-label, dose-escalation clinical trial designed to evaluate a peptide-based IL-22BP mRNA gene therapy in patients with refractory advanced malignant solid tumors. The investigational product uses a peptide delivery platform composed of natural amino acids, which is intended to improve biocompatibility, reduce toxicity, simplify manufacturing, and avoid key patent limitations associated with conventional lipid nanoparticle (LNP) systems. Unlike a traditional tumor vaccine, this intervention is designed as a targeted gene therapy that promotes intratumoral expression of IL-22BP protein to inhibit tumor progression. Preclinical toxicology studies of the peptide-mRNA complex have shown an acceptable safety profile, with no notable abnormalities in hematological or biochemical parameters. The study will use a standard "3+3" dose-escalation design to assess three fixed mRNA dose levels. The primary objective is to characterize the safety and tolerability of the IL-22BP gene formulation, and the secondary objective is to evaluate its preliminary antitumor activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intratumoral CP-IL22BP mRNA injection group | Experimental | Biological: CP-IL22BP mRNA intratumorally injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
- Interval from the last chemotherapy, radiotherapy, or surgery ≥28 days.
Key exclusion criteria (13 listed)
- 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.
- Active pulmonary tuberculosis, bacterial or fungal infection (≥Grade 2 per NCI-CTCAE version 5.0), active human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP-IL22BP mRNA intratumorally injectionCP-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. | Biological | Intratumoral CP-IL22BP mRNA injection group |
Primary outcome
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Time frame: From the first dose to the end of treatment at 9 weeks
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.
Number of participants with treatment discontinuation due to treatment-related adverse events during the first treatment cycle
Time frame: From the first dose to the end of treatment at 9 weeks
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.
3 secondary outcomes
Objective Response
Time frame: Time Frame: Up to 6 months from the date of the first dose.
Progression-Free Survival
Time frame: Up to 6 months from the date of the first dose.
Overall Survival
Time frame: Up to 12 months from the date of the first dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for mRNA Vaccine
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
RecruitingPhase 4
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations
SARS-CoV-2
RecruitingPhase 1
Phase 1 Study of Chlamydia Trachomatis mRNA Vaccine in Adults.
Chlamydia Trachomatis Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CP-IL22BP mRNA intratumorally injection in people with mRNA Vaccine and Solid Tumor Cancer, run by West China Hospital at 1 site 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 15 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 14 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 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingchen PXC Peng, Ph.D. (86+13108175138, 13108175138@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) (time frame: From the first dose to the end of treatment at 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2026.