New mRNA shot targets Hard-to-Treat cancers in early human test
NCT ID NCT07562815
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new mRNA medicine (NCP-IL-22BP mRNA) in 9 people with advanced solid tumors that have not responded to standard treatments. The medicine is injected directly into tumors to help the body fight cancer. The main goal is to check safety and find the right dose, with a secondary look at whether tumors shrink.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 9 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Apr 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced soft-tissue sarcoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
West China Hospital
Chengdu, Sichuan, 610000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can colorectal surgery patients go home in two days?
- New PET tracer aims to light up hidden cancer targets
- Can a personal navigator help young cancer patients through treatment?
- Can a smartwatch predict which cancer patients return to hospital?
- Can immunotherapy before surgery stop early oral cancer from returning?
- Two-Drug combo aims to stall advanced breast cancer