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New mRNA vaccine takes on tough cancers

NCT ID NCT07455617

Disease control Sponsor: Suzhou Abogen Biosciences Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-stage trial tests a new mRNA vaccine called ABO2102, designed to target cancers with specific KRAS mutations. About 101 adults with advanced solid tumors will receive the vaccine alone or with another drug (Sintilimab). The study focuses on safety and how the body responds, with a preliminary look at 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
ABO2102 (mRNA vaccine targeting KRAS mutations) and Sintilimab (anti-PD-1 antibody)
What this could lead to
If successful, this could point toward a new treatment option for people with hard-to-treat cancers that have KRAS mutations.
What could go wrong
This is an early Phase 1 trial with only 101 participants, so the main goal is safety, not proof of effectiveness. The treatment may not shrink tumors or could cause side effects.

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 101 people

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

Started

Mar 2026

Expected to finish

Feb 2030

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. ≥18 years of age at time of informed consent. 2. Have a genetically tested report confirmed by the investigator or complete genetic testing during the screening period, with evidence of harboring any of required KRAS mutations 3. Histopathologically and/or cytologically confirmed locally advanced or metastatic solid tumors. 4. According to RECIST v1.1, at least one measurable lesion is required. 5. No severe hematological, hepatic, renal or coagulation dysfunction; laboratory test results during the screening period must meet the respective criteria specified in the study protocol. 6. Females of childbearing potential and males who are involved in heterosexual activity must agree to practice highly effective contraception. Exclusion Criteria: 1. Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that have been cured, superficial bladder cancer, or carcinoma in situ of the breast or cervix. 2. Has known symptomatic central nervous system (CNS) metastases, or CNS metastases requiring local CNS-directed therapy . 3. Received KRAS cancer vaccine before. 4. History of severe (≥ Grade 3) hypersensitivity reactions to immunotherapy. 5. History of allogeneic organ transplantation or graft-versus-host disease (GVHD). 6. Any active infection (except for hepatitis virus infection) requires systemic treatment. 7. Absence of spleen 8. Known psychiatric disorder or drug abuse that may interfere with the trial requirements 9. Participant is pregnant or breastfeeding or expecting to conceive within the projected duration of the study. 10. Other conditions that Investigators consider inappropriate for enrollment.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced / metastatic solid tumor

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

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, China

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