CancerPhase 1NCT07562815
Safety and Tolerability of NCP-IL-22BP mRNA in Advanced Solid Tumors
A Phase 1 study testing 25 μg NCP-IL-22BP mRNA, 50 μg NCP-IL-22BP mRNA and 100 μg NCP-IL-22BP mRNA in people with Cancer, run by West China Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cancer
- What is being tested?
- 25 μg NCP-IL-22BP mRNA, 50 μg NCP-IL-22BP mRNA and 100 μg NCP-IL-22BP mRNA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2026to 28 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 and ≤70 years
- 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)
- ECOG Performance Status score: 0-1
- Estimated life expectancy ≥3 months
- At least 28 days since prior chemotherapy, radiotherapy, or surgery
- At least 6 weeks since prior use of nitrosoureas or mitomycin C
Show all 15Show fewer
- 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%
- Signed written informed consent
Who cannot join
- Participation in another clinical drug trial within 4 weeks
- Tumor located adjacent to major blood vessels or trachea
- Poorly controlled cardiac conditions: NYHA class >2 heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmias requiring treatment
- Pregnant or breastfeeding women
- Active pulmonary tuberculosis, bacterial or fungal infection (≥Grade 2 per NCI-CTCAE v5.0); HIV infection, active HBV or HCV infection
- History of psychotropic substance abuse that cannot be discontinued, or mental disorders
Show all 12Show fewer
- Active autoimmune disease or history of autoimmune disease (exceptions: vitiligo; childhood asthma in complete remission)
- Currently receiving immunosuppressive therapy
- History of drug abuse or known medical, psychological, or social conditions (e.g., alcoholism, drug addiction)
- Known allergy, hypersensitivity, or intolerance to IL-22BP or any excipient; history of severe allergic reactions to any drug, food, or vaccine
- Female subjects with pregnancy plans or male subjects whose partners have pregnancy plans from screening through 12 months after the last dose
- Any serious concomitant disease that, in the investigator's judgment, would jeopardize patient safety or ability to complete 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
West China Hospital
Chengdu, Sichuan, 610000
Xingchen Peng, 18980606753, pxx2014@scu.edu.cn
About this study
Official title: 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.
- Conditions
- Cancer
- Being tested
- 25 μg NCP-IL-22BP mRNA, 50 μg NCP-IL-22BP mRNA, 100 μg NCP-IL-22BP mRNA
- Keywords
- cancer, biotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25 μg NCP-IL-22BP mRNABiological
NCP-IL-22BP mRNA administered by intratumoral injection, 5 doses at weekly intervals
50 μg NCP-IL-22BP mRNABiological
NCP-IL-22BP mRNA administered by intratumoral injection, 5 doses at weekly intervals
100 μg NCP-IL-22BP mRNABiological
NCP-IL-22BP mRNA administered by intratumoral injection, 5 doses at weekly intervals
| Study group | Role | What they receive |
|---|---|---|
| NCP-IL-22BP mRNA Dose Level 1 (25 μg) | Experimental | Not described Receives: Biological: 25 μg NCP-IL-22BP mRNA |
| NCP-IL-22BP mRNA Dose Level 2 (50 μg) | Experimental | Not described Receives: Biological: 50 μg NCP-IL-22BP mRNA |
| NCP-IL-22BP mRNA Dose Level 3 (100 μg) | Experimental | Not described Receives: Biological: 100 μg NCP-IL-22BP mRNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities
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
Measured: From the first dose to 3 weeks post-dose. (approximately 3 weeks)
Secondary outcomes (4)
Objective Response Rate (ORR)
Proportion of subjects achieving complete response (CR) or partial response (PR) per RECIST v1.1
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.
Disease Control Rate
Proportion of subjects achieving CR, PR, or stable disease (SD) per RECIST v1.1
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.
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.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start28 Apr 2026 (estimated)
- Primary completion28 Apr 2027 (estimated)
- Study completion28 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 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
- Investigators
- Xingchen Peng, Principal investigator, The West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562815
- Sponsor's protocol ID
- 2026(936)
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07562815
- Acronym / sponsor ID
- 2026(936)
- Conditions
- Cancer
- Keywords
- cancer, biotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 28 Apr 2026 (estimated)
- Primary completion
- 28 Apr 2027 (estimated)
- Study completion
- 28 Dec 2027 (estimated)
- First posted
- 1 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NCP-IL-22BP mRNA Dose Level 1 (25 μg) | Experimental | Biological: 25 μg NCP-IL-22BP mRNA |
| NCP-IL-22BP mRNA Dose Level 2 (50 μg) | Experimental | Biological: 50 μg NCP-IL-22BP mRNA |
| NCP-IL-22BP mRNA Dose Level 3 (100 μg) | Experimental | Biological: 100 μg NCP-IL-22BP mRNA |
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 and ≤70 years
- 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)
- ECOG Performance Status score: 0-1
- Estimated life expectancy ≥3 months
- At least 28 days since prior chemotherapy, radiotherapy, or surgery
Key exclusion criteria (12 listed)
- Participation in another clinical drug trial within 4 weeks
- Tumor located adjacent to major blood vessels or trachea
- Poorly controlled cardiac conditions: NYHA class >2 heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmias requiring treatment
- Pregnant or breastfeeding women
- Active pulmonary tuberculosis, bacterial or fungal infection (≥Grade 2 per NCI-CTCAE v5.0); HIV infection, active HBV or 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 |
|---|---|---|
| 25 μg NCP-IL-22BP mRNANCP-IL-22BP mRNA administered by intratumoral injection, 5 doses at weekly intervals | Biological | NCP-IL-22BP mRNA Dose Level 1 (25 μg) |
| 50 μg NCP-IL-22BP mRNANCP-IL-22BP mRNA administered by intratumoral injection, 5 doses at weekly intervals | Biological | NCP-IL-22BP mRNA Dose Level 2 (50 μg) |
| 100 μg NCP-IL-22BP mRNANCP-IL-22BP mRNA administered by intratumoral injection, 5 doses at weekly intervals | Biological | NCP-IL-22BP mRNA Dose Level 3 (100 μg) |
Primary outcome
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
4 secondary outcomes
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.
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.
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.
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.
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 11 May 2026.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Xingchen Peng principal investigator
The West China Hospital
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 25 μg NCP-IL-22BP mRNA, 50 μg NCP-IL-22BP mRNA and 100 μg NCP-IL-22BP mRNA in people with 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 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: opening soon, as of the sponsor's last update on 11 May 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 Peng (18980606753, pxx2014@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (time frame: From the first dose to 3 weeks post-dose. (approximately 3 weeks)). 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 11 May 2026.