KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer

NCT07353645 | Recruiting Phase 1 DMC

• 1 other identifier: 2025-1111-02
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Colorectal Cancer; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicities (DLT)

  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)

  3 months post-first vaccination

• Proportion of patients with clearance of positive tumor markers (ctDNA and/or CEA/CA199)

  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.

• Recurrence-free survival (RFS)

  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)

  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.

Study Arms (1)

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.

Drug: KRAS Neoantigen Nanovaccine

Interventions

KRAS Neoantigen Nanovaccine DRUG

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.

Also known as: anti-PD-1 antibody, anti-CTLA4 antibody

Experimental Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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 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.
• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Pancreatic Neoplasms

Interventions

spartalizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Baorui Liu

  Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University

  STUDY CHAIR

Central Study Contacts

Baorui Liu

CONTACT

+86 025-83106666; baoruiliu@nju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 20, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2031
• Last Updated: April 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)