Advanced Pancreatic AdenocarcinomaPhase 1NCT07637786
Peptide Nanovaccine (ONVAX-01) Plus Anti-PD-1 Antibody and Chemotherapy in Advanced Pancreatic Cancer
A Phase 1 study testing ONVAX-01 plus Anti-PD-1 and Chemotherapy in people with Advanced Pancreatic Adenocarcinoma, run by Sichuan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Pancreatic Adenocarcinoma
- What is being tested?
- ONVAX-01 plus Anti-PD-1 and Chemotherapy
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2026to 1 Sep 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
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- 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.
Who cannot join
- • 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Zhong Wu, 85422474, wuzhong0057@163.com
About this study
Official title: An Exploratory Clinical Study of Peptide Nanovaccine (ONVAX-01) and Anti-PD-1 Antibody Combined With Chemotherapy for the Treatment of Advanced Pancreatic Cancer
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:
Read more
- Is the combination of the peptide nanovaccine (ONVAX-01), an anti-PD-1 antibody, and chemotherapy safe and well-tolerated?
- Does this combination treatment help shrink tumors or stop the progression of advanced pancreatic cancer?
Participants will be asked to:
- Receive doses of the peptide nanovaccine (ONVAX-01).
- Receive intravenous infusions of an anti-PD-1 antibody and standard chemotherapy.
- 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.
- Conditions
- Advanced Pancreatic Adenocarcinoma
- Being tested
- ONVAX-01 plus Anti-PD-1 and Chemotherapy
- Keywords
- Advanced pancreatic adenocarcinoma, Anti-PD-1 Antibody, Peptide Nanovaccine, Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONVAX-01 plus Anti-PD-1 and ChemotherapyDrug
The peptide nanovaccine (ONVAX-01) is administered via subcutaneous (SC) or intradermal (ID) injection, while the anti-PD-1 antibody and chemotherapy regimens are administered via intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| ONVAX-01 + Anti-PD-1 Antibody + Chemotherapy | Experimental | Participants with pancreatic ductal adenocarcinoma will receive a combination therapy of peptide nanovaccine (ONVAX-01), anti-PD-1, and standard chemotherapy.
Treatment Schema:
Induction Phase: Participants receive ONVAX-01 and anti-PD-1 in combination with investigator-selected chemotherapy (either AG regimen or NALIRIFOX regimen) for 6-12 cycles.
Maintenance Phase: Participants achieving clinical benefit (CR, PR, or SD) will continue treatment with ONVAX-01 and anti-PD-1.
Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of consent. Receives: Drug: ONVAX-01 plus Anti-PD-1 and Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From the first dose of study treatment up to 36 weeks after the last dose.
Secondary outcomes (4)
Objective Response Rate (ORR)
Measured: Up to disease progression or unacceptable toxicity (Up to approximately 24 months).
Disease Control Rate (DCR)
Measured: Up to disease progression or unacceptable toxicity (Up to approximately 24 months).
Progression-Free Survival (PFS)
Measured: Up to 24 months.
Overall Survival (OS)
Measured: Up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start20 Jun 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen-Yu Ding, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637786
- Sponsor's protocol ID
- ONVAX-01
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to protect patient privacy and maintain strict confidentiality in accordance with the study's informed consent form and the Institutional Review Board (IRB) regulations.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Peptide Nanovaccine (ONVAX-01) and Anti-PD-1 Antibody Combined With Chemotherapy for the Treatment of Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07637786
- Acronym / sponsor ID
- ONVAX-01
- Conditions
- Advanced Pancreatic Adenocarcinoma
- Keywords
- Advanced pancreatic adenocarcinoma, Anti-PD-1 Antibody, Peptide Nanovaccine, Chemotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 20 Jun 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is the combination of the peptide nanovaccine (ONVAX-01), an anti-PD-1 antibody, and chemotherapy safe and well-tolerated?
- Does this combination treatment help shrink tumors or stop the progression of advanced pancreatic cancer?
Participants will be asked to:
- Receive doses of the peptide nanovaccine (ONVAX-01).
- Receive intravenous infusions of an anti-PD-1 antibody and standard chemotherapy.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ONVAX-01 + Anti-PD-1 Antibody + Chemotherapy | Experimental | Drug: ONVAX-01 plus Anti-PD-1 and ChemotherapyParticipants with pancreatic ductal adenocarcinoma will receive a combination therapy of peptide nanovaccine (ONVAX-01), anti-PD-1, and standard chemotherapy. Treatment Schema: Induction Phase: Participants receive ONVAX-01 and anti-PD-1 in combination with investigator-selected chemotherapy (either AG regimen or NALIRIFOX regimen) for 6-12 cycles. Maintenance Phase: Participants achieving clinical benefit (CR, PR, or SD) will continue treatment with ONVAX-01 and anti-PD-1. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of consent. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- • Age between 18 and 75 years (inclusive).
Key exclusion criteria (14 listed)
- • Receipt of anti-tumor chemotherapy, radiotherapy, or immunotherapy within 2 weeks prior to the first dose of the study vaccine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONVAX-01 plus Anti-PD-1 and ChemotherapyThe peptide nanovaccine (ONVAX-01) is administered via subcutaneous (SC) or intradermal (ID) injection, while the anti-PD-1 antibody and chemotherapy regimens are administered via intravenous (IV) infusion. | Drug | ONVAX-01 + Anti-PD-1 Antibody + Chemotherapy |
Primary outcome
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the first dose of study treatment up to 36 weeks after the last dose.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to disease progression or unacceptable toxicity (Up to approximately 24 months).
Disease Control Rate (DCR)
Time frame: Up to disease progression or unacceptable toxicity (Up to approximately 24 months).
Progression-Free Survival (PFS)
Time frame: Up to 24 months.
Overall Survival (OS)
Time frame: Up to 36 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to protect patient privacy and maintain strict confidentiality in accordance with the study's informed consent form and the Institutional Review Board (IRB) regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONVAX-01 plus Anti-PD-1 and Chemotherapy in people with Advanced Pancreatic Adenocarcinoma, run by Sichuan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhong Wu (+8685422474, wuzhong0057@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From the first dose of study treatment up to 36 weeks after the last dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.