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Experimental mRNA injection takes on tough cancers

NCT ID NCT07040943

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This early-stage trial tests a new mRNA-based drug called IL-22BP in 6 adults with advanced solid tumors that have not responded to standard treatments. The drug is injected directly into tumors to see if it is safe and can shrink cancer. The study focuses on safety and tumor response, not a cure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IL-22BP mRNA injection
What this could lead to
If it works, this could point toward a new treatment option for patients with hard-to-treat solid tumors that have not responded to standard therapies.
What could go wrong
This is a very early Phase 1 trial with only 6 participants, so it is too small to prove effectiveness. The main goal is safety, and there is no guarantee the treatment will shrink tumors or work for others.

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

6 people

The number who actually took part.

Started

Jun 2025

Finished

Jul 2026

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 years old and ≤ 70 years old; 2. Patients with histopathologically confirmed, refractory to second-line treatment, advanced recurrent/metastatic malignant solid tumors and without standard clinical treatment regimens (such as patients with advanced soft tissue sarcoma, advanced head and neck squamous cell carcinoma, malignant melanoma, etc.); 3. Eastern Cooperative Oncology Group (ECOG) performance status score: 0 - 1; 4. Expected survival time ≥ 3 months; 5. More than 28 days since the last chemotherapy/radiotherapy/surgery; 6. More than 6 weeks since the last use of nitrosoureas or mitomycin C; 7. Main organ functions are in good condition; 8. Sign a written informed consent form. Exclusion Criteria: 1. Have participated in other drug clinical trials within 4 weeks; 2. The tumor is located close to major blood vessels or the trachea; 3. Patients with uncontrolled cardiac clinical symptoms or diseases, such as heart failure of NYHA class II or above, unstable angina pectoris, having had a myocardial infarction within 1 year, and having clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention. 4. For female subjects: pregnant or lactating women. 5. Patients have active tuberculosis, bacterial or fungal infections (≥ grade 2 of NCI-CTCAE 5.0); have active HIV infection, active HBV infection, or HCV infection. 6. Those with a history of psychotropic drug abuse who are unable to quit or have mental disorders; 7. Subjects have any active autoimmune diseases or a history of autoimmune diseases (such as, but not limited to: uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or those whose asthma in childhood has been completely relieved and who do not require any intervention in adulthood can be included; subjects with asthma that requires bronchodilators for medical intervention cannot be included). 8. Subjects are currently receiving immunosuppressive treatment. 9. Have a history of drug abuse or known medical, psychological, or social conditions, such as a history of alcoholism or drug use. 10. Known to be allergic, hypersensitive, or intolerant to the studied IL-22BP (including any excipients). Have a severe allergy history to any drugs, foods, or vaccines in the past, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local allergic necrotizing reaction (Arthus reaction), etc. 11. From the screening period to 12 months after the completion of drug injection, female subjects have pregnancy plans or the partners of male subjects have pregnancy plans. 12. According to the investigator's judgment, there are concomitant diseases that seriously endanger patient safety or affect the patient's completion of 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.

Contacts and locations

Locations

  • Department of Radiation Oncology

    Chengdu, Sichuan, 610000, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610000, China

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