Peptide Nanovaccine (ONVAX-01) Plus Anti-PD-1 Antibody and Chemotherapy in Advanced Pancreatic Ca… (NCT07637786) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Peptide Nanovaccine (ONVAX-01) Plus Anti-PD-1 Antibody and Chemotherapy in Advanced Pancreatic Cancer
China9 participantsStarted 2026-06-20
Plain-language summary
The goal of this clinical trial is to evaluate the safety and preliminary effectiveness of a new combination therapy in patients with advanced pancreatic cancer.
The main questions it aims to answer are:
1. Is the combination of the peptide nanovaccine (ONVAX-01), an anti-PD-1 antibody, and chemotherapy safe and well-tolerated?
2. Does this combination treatment help shrink tumors or stop the progression of advanced pancreatic cancer?
Participants will be asked to:
1. Receive doses of the peptide nanovaccine (ONVAX-01).
2. Receive intravenous infusions of an anti-PD-1 antibody and standard chemotherapy.
3. Undergo regular physical exams, blood tests, and imaging scans (such as CT or MRI) to monitor their health and the tumor's response to the treatment.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 childbearin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From the first dose of study treatment up to 36 weeks after the last dose.