MRNA injection aims to turn cold tumors hot

NCT ID NCT06088004

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 23, 2026 · Last updated Sep 24, 2026 · Updated 1 time

Summary

Researchers are testing an experimental mRNA injection called ABO2011 in adults with advanced solid tumors that have worsened after standard treatment. The injection delivers genetic instructions for interleukin-12, a protein that can stir up an immune response, directly into the tumor. Participants receive ABO2011 alone or combined with toripalimab, an immunotherapy drug. The trial measures safety, how the body processes the treatment, and whether tumors shrink.

What this could mean

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

Active substance
An mRNA injection that instructs tumors to make interleukin-12, given alone or with the immunotherapy drug toripalimab
What this could lead to
If it works, this approach could offer a new way to trigger an immune attack on solid tumors that have resisted other treatments.
What could go wrong
This is an early-phase trial with a small number of participants, so safety and benefit are still unproven. Injecting mRNA into tumors may cause immune-related side effects, and the combination could fail to shrink tumors.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 218 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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. Subjects must be ≥18 years olde. 2. Ability to sign informed consent, including compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol. 3. Histopathology or cytology confirmed Advanced solid tumors; 4. Failed of previous systemic treatment or required treatment histories for selected tumor types; 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 6. Expected survival greater than 12 weeks. 7. At least one superficial or deep lesion for intratumoral injection and biopsy. 8. Meet the required level of organ function. 9. Female patients are postmenopausal or, if women of childbearing potential, have a urine pregnancy or a blood pregnancy that is negative. At the same time, men of childbearing potential and women of childbearing potential voluntarily use effective contraception, including abstinence or effective contraception (e.g., intrauterine or implantable contraceptives, oral contraceptives, injectable or implantable contraceptives, extended-release local contraceptives, intrauterine devices \[IUDs\], condoms \[males\], diaphragms, cervical caps, etc.) from the time of signing the ICF until 120 days after the end of treatment. Exclusion Criteria: 1. Other malignancies within the previous 5 years, with the exception of cured basal cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of breast, and carcinoma in situ of the cervix. 2. Central nervous system tumors or metastases with clinical symptoms or asymptomatic brain metastases requiring steroids control. 3. History of serious cardiac disease, e.g., New York Heart Association (NYHA) ≥ Grade 2 cardiac failure, history of transmural myocardial infarction, unstable angina, poorly controlled arrhythmia, myocardial infarction within 6 months prior to enrollment, or arrhythmias requiring antiarrhythmic therapy (β-blockers, calcium channel blockers, and digoxin are allowed). QTcF \> 480 ms. 4. Poorly controlled clinical complications, including, but not limited to, uncontrolled hypertension with both antihypertensive agents Hypertension and hypoglycemic treatment not Controlled type 2 diabetes, poorly controlled pleural, ascites, or other serious diseases requiring systemic treatment. 5. Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc.; type 1 diabetes mellitus, hypothyroidism controlled by replacement therapy only, and skin diseases that do not require whole body therapy (eg, vitiligo, psoriasis) may be included in the trial. 6. The subject carried: Known Human Immunodeficiency Virus (HIV); Active hepatitis B virus infection; Active hepatitis C virus infection. 7. Thrombotic disease or use of full-dose anticoagulant drugs within 6 months prior to screening. 8. Radiotherapy within 14 days prior to the first dose. 9. Live or live attenuated vaccines or other vaccines within 30 days prior to the first dose may be determined by the investigator's comprehensive assessment. 10. Major surgery within 28 days prior to the first dose or non-study-related minor surgery within 14 days prior to the first dose. 11. Immunosuppressants or other immunomodulatory medications are required within 4 weeks prior to the first dose, but physiologic doses of systemic steroids are allowed or topical. Topical use should not exceed the dose recommended in the package insert or have any signs of systemic exposure; or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation requiring the use of immunosuppressants or other immunomodulatory drugs. 12. Acute toxic effects of prior anticancer chemotherapy or immunotherapy have not been stable, or significant post-treatment toxicities have been observed. 13. Any systemic anti-tumor therapy with specific washout windows. 14. Presence of clinically significant pulmonary fibrosis or interstitial pneumonia. 15. Presence of active infections, including bacteria, fungi, viruses, and tuberculosis. 16. Active bleeding, including but not limited to gastrointestinal bleeding, hemoptysis, etc. 17. History of immediate severe allergic reactions prior to the first dose. 18. Other conditions that may increase the risk associated with the study drug, or affect the study compliance, which the investigator considers unsuitable for participation in 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

    5 sites. 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

  • Cancer Hospital Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, China

  • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

    RECRUITING

    Shenzhen, China

  • Guangxi Medical University Cancer Hospital

    RECRUITING

    Nanning, China

  • Shanxi Cancer hospital

    RECRUITING

    Shanxi, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, China

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