Experimental vaccine combo takes on tough pancreatic cancer
NCT ID NCT07637786
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests a new peptide nanovaccine (ONVAX-01) together with an anti-PD-1 antibody and standard chemotherapy in 9 people with advanced pancreatic cancer that has worsened after prior treatment. The main goals are to see if the combination is safe and whether it can shrink tumors or stop the cancer from growing. Participants receive the vaccine as a shot under the skin and the other drugs through an IV, along with regular checkups and scans.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- peptide nanovaccine (ONVAX-01) plus an anti-PD-1 antibody and chemotherapy
- What this could lead to
- If it works, this could point toward a new combination treatment that shrinks tumors or slows disease progression in advanced pancreatic cancer.
- What could go wrong
- This is a very early phase 1 trial with only 9 participants, so results may not apply broadly. The combination may cause significant side effects or fail to show benefit.
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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 9 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 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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18 to 75 years
- 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.
Inclusion Criteria: * • Age between 18 and 75 years (inclusive). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Histologically confirmed, KRAS-mutated, unresectable metastatic pancreatic ductal adenocarcinoma (PDAC). * Documented disease progression after at least one prior line of systemic therapy. * Estimated life expectancy of ≥ 12 weeks. * At least one measurable objective tumor lesion according to RECIST v1.1. The maximum diameter must be ≥ 1 cm by spiral CT, or ≥ 2 cm by standard CT or MRI; imaging must be performed within 28 days prior to enrollment. * Adequate bone marrow and organ function, defined as follows (without the use of hematopoietic growth factors or blood transfusions within 7 days prior to testing): * Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L, platelet count ≥ 75 × 10\^9/L, and hemoglobin ≥ 90 g/L. * Hepatic: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN. * Renal: Creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula). * Coagulation: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN. * Cardiac: Normal electrocardiogram (ECG) or abnormal ECG deemed clinically insignificant by the investigator. * Urinalysis: Urine protein \< 2+; if urine protein is ≥ 2+, a 24-hour urine protein quantification must be \< 1.0 g. * Participants of childbearing potential must agree to use highly effective contraceptive measures from study entry throughout the study period. * Participants with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection must have received at least 14 days of continuous antiviral therapy prior to the first study dose. HBV DNA titer must be ≤ 500 IU/mL (or 2500 copies/mL) and HCV RNA must be below the lower limit of detection. Participants must be willing to continue effective antiviral therapy during the study. Exclusion Criteria: * • Receipt of anti-tumor chemotherapy, radiotherapy, or immunotherapy within 2 weeks prior to the first dose of the study vaccine. * History of other malignancies, except adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, non-muscle invasive bladder cancer (Ta and TIS), or other malignancies curatively treated at least 5 years prior to enrollment. * Uncontrolled concomitant diseases, including but not limited to active bacterial or fungal infections, symptomatic congestive heart failure, unstable angina, or cardiac arrhythmias. * Prior treatment with any antibody or drug targeting T-cell co-regulatory proteins (immune checkpoints), such as anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-OX-40, anti-CD137, anti-TIM-3, or anti-LAG-3 antibodies. * Human Immunodeficiency Virus (HIV) infection, or active uncontrolled HBV (HBV DNA ≥ 500 IU/mL) or HCV infection. * Uncontrolled coronary artery disease, asthma, cerebrovascular disease, or any other medical conditions deemed unsuitable for enrollment by the investigator. * Active autoimmune disease, primary or secondary immunodeficiency, or current treatment with immunosuppressive medications. * Pregnant or lactating women. * Receipt of any prophylactic vaccines for infectious diseases within 4 weeks prior to the first dose, or planned vaccination during the study up to 8 weeks after the last dose. * History of severe allergic reactions to prior prophylactic vaccines. * Known allergy or hypersensitivity to the investigational drugs or any of their excipients. * History of substance abuse, or any clinical, psychological, or social factors that would preclude the administration of immunotherapy. * Significant weight loss (≥ 10% of body weight) within 6 weeks prior to enrollment. * Any other condition or uncertainty that, in the investigator's judgment, could compromise patient safety or compliance with the study protocol.
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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
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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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West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New drug candidate takes aim at Hard-to-Treat pancreatic cancer
- Can a Two-Drug combo tame Hard-to-Treat pancreatic cancer?
- Can a One-Two punch of radiation and immunotherapy tame pancreatic cancer?
- Can we predict and treat cancer wasting better? a new study investigates
- Can a Pan-RAS inhibitor outsmart pancreatic cancer?