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New mRNA shot targets Hard-to-Treat cancers in early human test

NCT ID NCT07562815

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.