Colorectal CancerPhase 1/2NCT07353645
KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer
A Phase 1/2 study testing KRAS Neoantigen Nanovaccine in people with Colorectal Cancer and Pancreatic Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This clinical trial will utilize a neoantigen nanovaccine constructed from the bacterial membranes of an engineered Lactococcus lactis strain (FOLactis). This platform, independently developed by our center, expresses KRAS antigenic peptides. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Pancreatic Cancer
- What is being tested?
- KRAS Neoantigen Nanovaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2026to 1 Jan 2031
- Phase
- Phase 1/2
- 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 ≥18 years and ≤75 years, with an ECOG performance status of 0-1.
- Patients with histologically confirmed colorectal adenocarcinoma or pancreatic adenocarcinoma who have undergone radical resection (R0) and completed at least 4 cycles of postoperative adjuvant chemotherapy.
- Postoperative pathological stage for colorectal cancer is IIIA, IIIB, or IIIC. For pancreatic cancer, postoperative pathological stage is I, II, or III. The tumor must harbor at least one of the following KRAS hotspot mutations: G12D, G12V, G12R, G12A, G12S, G12C, or G13D.
- No radiological evidence of tumor recurrence or metastasis.
- Patients must meet the following hematologic criteria: Lymphocyte count ≥0.5×10⁹/L, neutrophil count ≥1.5×10⁹/L, white blood cell count >2.5×10⁹/L; Hemoglobin ≥90 g/L; Platelet count ≥90×10⁹/L.
- Patients must meet the following biochemical criteria: Total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤1.5 × ULN; Serum creatinine ≤1.5 × ULN or creatinine clearance ≥30 mL/min.
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- Patients must meet the following coagulation criteria: INR or PTT ≤1.5 × ULN.
- Patients of childbearing potential must employ adequate contraception or other birth control methods before enrollment and throughout the trial.
- Signed informed consent form has been obtained.
- Ability to comply with the study protocol and follow-up procedures.
Who cannot join
- Patients with colorectal cancer exhibiting microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) or harboring BRAF mutations.
- Pancreatic cancer patients with neuroendocrine tumor components are excluded.
- Patients with a history of other malignancies, except for carcinoma in situ of the cervix, treated squamous cell carcinoma or bladder epithelial tumors (Ta and TIS), or other malignancies that have been curatively treated (at least 5 years prior to enrollment).
- Prior treatment with anticancer vaccines or any antibodies targeting T-cell co-regulatory proteins (e.g., anti-PD1, anti-PDL1, or anti-CTLA4).
- Patients with HIV, HCV, or HBV infection; uncontrolled coronary artery disease or asthma; uncontrolled cerebrovascular disease; or any other condition deemed by the investigator as grounds for exclusion.
- Patients who are on immunosuppressants or systemic corticosteroid therapy for immunosuppressive purposes (at a dose >10 mg/day prednisone or equivalent) and have continued use within 2 weeks prior to enrollment.
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- Poorly controlled cardiac clinical symptoms or diseases, such as: Heart failure of NYHA Class II or higher; Unstable angina; Myocardial infarction within the past year; Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; QTc >450 ms (males); QTc >470 ms (females).
- Abnormal coagulation function (INR >2.0, PT >16 s), bleeding tendency, or current thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin or low molecular weight heparin is allowed.
- Patients with active infection; unexplained fever ≥38.5°C within 7 days prior to medication; baseline white blood cell count >15×10⁹/L; or suppurative and chronic infections with non-healing wounds.
- Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
- Substance abuse, or clinical, psychological, or social factors that may affect the provision of informed consent or the conduct of the study.
- Known or suspected allergy to drugs used in immunotherapy.
- Inability to undergo immunological and clinical follow-up assessments.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Participation in other interventional drug clinical trials concurrently.
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, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
Nanjing, Jiangsu, 210008
chu950518@163.com
About this study
Official title: Phase I/II Clinical Study of KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer With High Risk of Recurrence
This clinical trial will utilize a neoantigen nanovaccine constructed from the bacterial membranes of an engineered Lactococcus lactis strain (FOLactis). This platform, independently developed by our center, expresses KRAS antigenic peptides. The vaccine will be administered as adjuvant therapy to post-operative patients with colorectal or pancreatic cancer who carry KRAS mutations and are at high risk of recurrence. The study aims to assess the safety, immunogenicity, and preliminary efficacy of this neoantigen nanovaccine in a clinical setting.
Read the detailed description
- Pre-vaccination Screening: Detection of KRAS hotspot mutations in the patient's tumor tissue.
- Vaccine Composition and Administration: The vaccine utilizes a neoantigen nanovaccine constructed from the bacterial membranes of engineered Lactococcus lactis, independently developed by the Cancer Center of Nanjing Drum Tower Hospital. It is administered via subcutaneous or intralymph node injection. The study consists of two phases: Dose Escalation and Dose Expansion. The Dose Escalation phase involves the vaccine alone, while the Dose Expansion phase combines the vaccine with anti-PD-1 antibody and anti-CTLA-4 antibody, as detailed below: Dose Escalation Phase: Conducted according to a "3+3" design. The neoantigen nanovaccine is tested at two dose levels: 1.5mg and 3.0mg. Each injection has a total volume of 2.0ml, administered subcutaneously or via ultrasound-guided injection into bilateral inguinal lymph nodes. Vaccination Schedule: A total of 9 vaccinations are planned on Days 1, 4, 8, 15, 22, 43, 64, 85, and 106. Vaccinations #1 and #5-#9: Ultrasound-guided bilateral inguinal lymph node injection combined with subcutaneous injection in the subdeltoid region,accompanied by intravenous cyclophosphamide (200mg/m²) on the same day. Vaccinations #2, #3, and #4: Subcutaneous injection. Efficacy and Safety Monitoring: Radiographic efficacy evaluations are performed every 12 weeks for the first two years post-surgery, and every 24 weeks thereafter. Adverse events are assessed following each vaccination. Dose Expansion Phase: The vaccine dose for this phase is determined based on results from the Dose Escalation phase. The vaccination procedure remains the same. Twenty eligible post-operative colorectal cancer patients and twenty eligible post-operative pancreatic cancer patients will be enrolled for continued observation of efficacy and side effects. The nanovaccination schedule follows the Dose Escalation phase protocol. The anti-CTLA-4 antibody is administered on D1 and D43. The anti-PD-1 antibody is administered starting on the first day of vaccination, once every three weeks, until disease progression, unacceptable toxicity, or completion of 6 cycles, whichever occurs first.
- Immunological Follow-up: Hematological immune monitoring, including lymphocyte immunophenotyping and cytokine profiling, is performed pre-vaccination and on Days 1, 22, 43, 85, and 106 after the first vaccination.
- Conditions
- Colorectal Cancer, Pancreatic Cancer
- Being tested
- KRAS Neoantigen Nanovaccine
- Medical subject headings
- Colorectal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KRAS Neoantigen NanovaccineDrug
Also called anti-PD-1 antibody, anti-CTLA4 antibody
The vaccine utilizes a neoantigen nanovaccine constructed from the bacterial membranes of engineered Lactococcus lactis, independently developed by the Cancer Center of Nanjing Drum Tower Hospital. It is administered via subcutaneous or intralymph node injection.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | neoantigen nanovaccine constructed from the bacterial membranes of engineered Lactococcus lactis, independently developed by the Cancer Center of Nanjing Drum Tower Hospital. It is administered via subcutaneous or intralymph node injection. Receives: Drug: KRAS Neoantigen Nanovaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLT)
Measured: From clinical trial enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to five years.
Secondary outcomes (6)
Proportion of patients with a decrease in positive tumor markers (ctDNA and/or CEA/CA199)
Measured: 3 months post-first vaccination
Proportion of patients with clearance of positive tumor markers (ctDNA and/or CEA/CA199)
Measured: 3 months post-first vaccination
KRAS neoantigen specific T cells
From clinical trial enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to five years.
Measured: From clinical trial enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to five years.
Recurrence-free survival (RFS)
Measured: From clinical trial enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to five years.
Correlation between neoantigen-specific T-cell frequency and dynamic changes in tumor markers (ctDNA and/or CEA/CA199)
Unit of Measure: Percent change in concentration (%) Measurement Tool/Description: The frequency of neoantigen-specific T cells (as a percentage of CD8+ T cells) quantified using multiparameter flow cytometry in peripheral blood or tumor microenvironment will be correlated (e.g., using Pearson or Spearman correlation coefficient) with the percent change in serum tumor marker levels (ctDNA and/or CEA/CA199).
Measured: From clinical trial enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to five years.
Association between neoantigen-specific T-cell frequency and recurrence-free survival (RFS)
Unit of Measure: Months Measurement Tool/Description: Assessment will be based on radiographic evaluation and clinical follow-up.The frequency of neoantigen-specific T cells (as a percentage of CD8+ T cells) quantified using multiparameter flow cytometry]in peripheral blood or tumor microenvironment will be correlated (e.g., using Pearson or Spearman correlation coefficient) with time in months from the date of surgery to the date of first documented disease recurrence or death from any cause.
Measured: From the date of surgery/treatment initiation to the date of first documented disease recurrence or death from any cause. Assessment will be based on radiographic evaluation and clinical follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start23 Mar 2026
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baorui Liu, Study chair, Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353645
- Sponsor's protocol ID
- 2025-1111-02
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Study of KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer With High Risk of Recurrence
- ClinicalTrials.gov ID
- NCT07353645
- Acronym / sponsor ID
- 2025-1111-02
- Conditions
- Colorectal Cancer, Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 20 Jan 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.
This clinical trial will utilize a neoantigen nanovaccine constructed from the bacterial membranes of an engineered Lactococcus lactis strain (FOLactis). This platform, independently developed by our center, expresses KRAS antigenic peptides. The vaccine will be administered as adjuvant therapy to post-operative patients with colorectal or pancreatic cancer who carry KRAS mutations and are at high risk of recurrence. The study aims to assess the safety, immunogenicity, and preliminary efficacy of this neoantigen nanovaccine in a clinical setting.
Detailed description
- Pre-vaccination Screening: Detection of KRAS hotspot mutations in the patient's tumor tissue.
- Vaccine Composition and Administration: The vaccine utilizes a neoantigen nanovaccine constructed from the bacterial membranes of engineered Lactococcus lactis, independently developed by the Cancer Center of Nanjing Drum Tower Hospital. It is administered via subcutaneous or intralymph node injection. The study consists of two phases: Dose Escalation and Dose Expansion. The Dose Escalation phase involves the vaccine alone, while the Dose Expansion phase combines the vaccine with anti-PD-1 antibody and anti-CTLA-4 antibody, as detailed below: Dose Escalation Phase: Conducted according to a "3+3" design. The neoantigen nanovaccine is tested at two dose levels: 1.5mg and 3.0mg. Each injection has a total volume of 2.0ml, administered subcutaneously or via ultrasound-guided injection into bilateral inguinal lymph nodes. Vaccination Schedule: A total of 9 vaccinations are planned on Days 1, 4, 8, 15, 22, 43, 64, 85, and 106. Vaccinations #1 and #5-#9: Ultrasound-guided bilateral inguinal lymph node injection combined with subcutaneous injection in the subdeltoid region,accompanied by intravenous cyclophosphamide (200mg/m²) on the same day. Vaccinations #2, #3, and #4: Subcutaneous injection. Efficacy and Safety Monitoring: Radiographic efficacy evaluations are performed every 12 weeks for the first two years post-surgery, and every 24 weeks thereafter. Adverse events are assessed following each vaccination. Dose Expansion Phase: The vaccine dose for this phase is determined based on results from the Dose Escalation phase. The vaccination procedure remains the same. Twenty eligible post-operative colorectal cancer patients and twenty eligible post-operative pancreatic cancer patients will be enrolled for continued observation of efficacy and side effects. The nanovaccination schedule follows the Dose Escalation phase protocol. The anti-CTLA-4 antibody is administered on D1 and D43. The anti-PD-1 antibody is administered starting on the first day of vaccination, once every three weeks, until disease progression, unacceptable toxicity, or completion of 6 cycles, whichever occurs first.
- Immunological Follow-up: Hematological immune monitoring, including lymphocyte immunophenotyping and cytokine profiling, is performed pre-vaccination and on Days 1, 22, 43, 85, and 106 after the first vaccination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: KRAS Neoantigen Nanovaccineneoantigen nanovaccine constructed from the bacterial membranes of engineered Lactococcus lactis, independently developed by the Cancer Center of Nanjing Drum Tower Hospital. It is administered via subcutaneous or intralymph node injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years and ≤75 years, with an ECOG performance status of 0-1.
- Patients with histologically confirmed colorectal adenocarcinoma or pancreatic adenocarcinoma who have undergone radical resection (R0) and completed at least 4 cycles of postoperative adjuvant chemotherapy.
- Postoperative pathological stage for colorectal cancer is IIIA, IIIB, or IIIC. For pancreatic cancer, postoperative pathological stage is I, II, or III. The tumor must harbor at least one of the following KRAS hotspot mutations: G12D, G12V, G12R, G12A, G12S, G12C, or G13D.
- No radiological evidence of tumor recurrence or metastasis.
- Patients must meet the following hematologic criteria: Lymphocyte count ≥0.5×10⁹/L, neutrophil count ≥1.5×10⁹/L, white blood cell count >2.5×10⁹/L; Hemoglobin ≥90 g/L; Platelet count ≥90×10⁹/L.
Key exclusion criteria (15 listed)
- Patients with colorectal cancer exhibiting microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) or harboring BRAF mutations.
- Pancreatic cancer patients with neuroendocrine tumor components are excluded.
- Patients with a history of other malignancies, except for carcinoma in situ of the cervix, treated squamous cell carcinoma or bladder epithelial tumors (Ta and TIS), or other malignancies that have been curatively treated (at least 5 years prior to enrollment).
- Prior treatment with anticancer vaccines or any antibodies targeting T-cell co-regulatory proteins (e.g., anti-PD1, anti-PDL1, or anti-CTLA4).
- Patients with HIV, HCV, or HBV infection; uncontrolled coronary artery disease or asthma; uncontrolled cerebrovascular disease; or any other condition deemed by the investigator as grounds for exclusion.
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 |
|---|---|---|
| KRAS Neoantigen NanovaccineAlso: anti-PD-1 antibody, anti-CTLA4 antibodyThe vaccine utilizes a neoantigen nanovaccine constructed from the bacterial membranes of engineered Lactococcus lactis, independently developed by the Cancer Center of Nanjing Drum Tower Hospital. It is administered via subcutaneous or intralymph node injection. | Drug | Experimental Group |
Primary outcome
Dose-limiting toxicities (DLT)
Time frame: From clinical trial enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to five years.
6 secondary outcomes
Proportion of patients with a decrease in positive tumor markers (ctDNA and/or CEA/CA199)
Time frame: 3 months post-first vaccination
Proportion of patients with clearance of positive tumor markers (ctDNA and/or CEA/CA199)
Time frame: 3 months post-first vaccination
KRAS neoantigen specific T cells
Time frame: From clinical trial enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to five years.
Recurrence-free survival (RFS)
Time frame: From clinical trial enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to five years.
Correlation between neoantigen-specific T-cell frequency and dynamic changes in tumor markers (ctDNA and/or CEA/CA199)
Time frame: From clinical trial enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to five years.
Association between neoantigen-specific T-cell frequency and recurrence-free survival (RFS)
Time frame: From the date of surgery/treatment initiation to the date of first documented disease recurrence or death from any cause. Assessment will be based on radiographic evaluation and clinical follow-up.
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 15 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Baorui Liu study chair
Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing KRAS Neoantigen Nanovaccine in people with Colorectal Cancer and Pancreatic Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 10 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 15 Apr 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Baorui Liu (+86 025-83106666, baoruiliu@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (DLT) (time frame: From clinical trial enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to five years.). 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 15 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.