Personalized vaccine aims to train immune system against cancer
NCT ID NCT05741242
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial is testing a personalized vaccine made from unique proteins (neoantigens) found in a person's tumor. The goal is to see if the vaccine is safe and can help slow or stop cancer growth in people with solid tumors, including pancreatic cancer. About 136 participants with local or metastatic solid tumors will receive the vaccine. The study is currently enrolling by invitation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Personalized synthetic long peptide vaccine
- What this could lead to
- If successful, this could lead to a new personalized vaccine that helps the immune system fight solid tumors, potentially slowing or stopping cancer growth.
- What could go wrong
- This is an early-phase trial (phase 1b/2) with only 136 participants, so results may not apply to all patients. The vaccine is personalized, making it complex and costly, and it may not work for everyone.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 136 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2022
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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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
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Patients must satisfy the following criteria to be enrolled in the protocol: Main Inclusion Criterion: Pancreatic 1. Patients who have local or metastatic pancreatic adenocarcinoma and have started first line therapy of Folfirinox (physician's choice for any concomitant therapies) 2. Patients who have undergone somatic tumor sequencing should consider FDA-approved pan-solid tumor therapies if they harbor an FDA-approved somatic alteration. For example, Entrectinib or Larotrectinib (if NTRK gene fusion- positive), Selpercatinib (if RET gene fusion-positive), Pembrolizumab (if MSI-H, dMMR, or TMB-H\[≥10 mut/Mb\]), and PARP inhibitors (BRCA mutations). Glioblastoma 1\. Patients who are within 6 months of diagnosis and have detectable disease as determined by investigator assessment at the start of vaccine administration. Basket 1\. Patients with local or metastatic malignancies, limited treatment options, and an estimated 5-year survival of less than 50% are eligible for enrollment in this cohort. Other Inclusion Criteria: 1. \>= 12 years of age. 2. ECOG performance status ≤ 2 or Karnofsky score of \>=70. 3. Adequate organ function allowing favorable benefit to risk ratio per the treating physician 4. Systemic corticosteroid therapy is permitted provided dosing is no greater than 4 mg per day (dexamethasone or equivalent) on the day of vaccine administration. 5. Ability to understand and willingness to sign an IRB approved written informed consent document. Exclusion Criteria: 1. History of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty or known allergy to a component of the neoantigen synthetic long peptide vaccine. 2. Intercurrent illness requiring chronic use of medications that may interfere with rescue medications for treatment of vaccine-related anaphylaxis or attenuate immune response to vaccine treatment (immunosuppressive therapies). 3. Psychiatric illness or social situations that would limit compliance with study requirements. 4. History of pre-existing immunodeficiency disorder or autoimmune condition requiring immunosuppressive therapy that would preclude response to vaccine. 5. Females of childbearing potential may participate provided they agree to practice abstinence; and, if heterosexually active, agree to use at least 2 highly effective contraceptive methods throughout the study and for 3 months following the last dose of study drug; and have a negative serum pregnancy test. 6. Females of non-childbearing potential must be post-menopausal or have been surgically sterilized. 7. Male subjects with a female partner of childbearing potential must agree to practice abstinence or to use a physician-approved contraceptive method throughout the study and for 3 months following the last dose of study drug.
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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.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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
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Anna Gattani MD PC
New York, New York, 10028, United States
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Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
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Precision NextGen Oncology & Research Center
Beverly Hills, California, 90212, United States
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Quest Clinical Research
San Francisco, California, 94115, United States
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St. Louis Cancer Care
Bridgeton, Missouri, 63044, United States
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