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Tailor-Made vaccine aims to train immune system against cancer

NCT ID NCT07680582

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This early-phase trial is testing a personalized cancer vaccine (ABO2109) combined with an immunotherapy drug (toripalimab) in people with solid tumors. The vaccine is custom-made for each patient to target their specific cancer. The study aims to check the safety of this combination and see how well it triggers an immune response. Participants include those who have had surgery for their cancer or have advanced disease, and the trial will also look for early signs that the vaccine might help prevent the cancer from coming back.

What this could mean

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

Active substance
personalized cancer vaccine (ABO2109) and toripalimab (anti-PD-1 antibody)
What this could lead to
If successful, this could pave the way for a personalized vaccine that trains the immune system to fight residual cancer cells after surgery, potentially reducing recurrence risk.
What could go wrong
This is a very early (Phase 1) study with only 60 participants, so safety and effectiveness are not yet proven. The vaccine is personalized, making it complex and costly, and it may not work for all tumor types.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 60 people

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

Started

Jun 2026

Expected to finish

Feb 2031

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 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.

Key Inclusion Criteria: 1. ≥18 years of age at time of informed consent 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 3. Life expectancy of ≥6 months 4. Patient diagnosed with solid tumors and is receiving perioperative and/or adjuvant anti-cancer therapy, or patients with advanced solid tumors 5. No evidence of disease progression per investigator within 28 days before the first dose of study intervention 6. Sufficient organ function 7. Female patients must meet both of the criteria: a) Surgically sterile, or postmenopausal for ≥2 years, or women of childbearing potential with a negative pregnancy test and willing to use effective contraception during the study and for at least 90 days after the last study dose. Use of progesterone-containing contraceptives is not permitted. b) Agree not to breastfeed during the study and for at least 90 days after the last study dose.Male patients must meet the following criteria:If not surgically sterile and potentially engaging in sexual activity that could lead to pregnancy, agree to use effective contraception during the study and for at least 90 days after the last study dose. Key Exclusion Criteria: 1. For perioperative or adjuvant therapy setting, participants have received systemic anti-tumor treatment previously 2. Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that has been cured, or superficial bladder cancer, carcinoma in situ of the breast, carcinoma in situ of the cervix, thyroid cancer 3. Presence of active or prior history of interstitial lung disease, tuberculosis, or any other condition known to compromise pulmonary function. 4. Presence of active infections 5. History of severe cardiovascular or cerebrovascular diseases occurring within 6-month prior to study treatment 6. Known hypersensitivity to the active ingredients or excipients of ABO2109 or toripalimab.

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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

  • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

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