Personalized Neoantigen Peptide Vaccines for Solid Tumors

Inclusion Criteria:

1. Age: 20 years or older.

2. Language proficiency: Able to read and understand Thai clearly.

3. Consent: Willing to provide informed consent and sign a participation agreement.

4. Life expectancy: Estimated to be at least 6 months from the date of consent.

5. Eligibility from prior research: Must have participated in the SQK01-002A researchproject and have tumor tissue confirmed as suitable for neoantigen peptide vaccineproduction.

6. Performance status: ECOG performance status of 0-2 with stable organ function, norapid disease progression, or impending organ failure.

7. Cancer diagnosis: Clinically and pathologically confirmed cancer diagnosis, withsupporting radiological evidence.

8. Cancer stage-specific criteria: i. Advanced cancer: Suitable for immune checkpoint inhibitors (ICIs) and showsresistance to prior therapies, with measurable lesions based on mRECIST1.1 criteria. ii. Early-stage cancer: High recurrence risk despite prior surgery and/orradiotherapy, with no current adjuvant treatment standard.

9. Laboratory parameters: i. Lymphocyte count ≥ 800 cells/μL. ii. Neutrophil count ≥ 1,500 cells/μL. iii.Platelet count ≥ 75,000 cells/μL. iv. AST ≤ 2.5 times the upper limit of normal (ULN). v. ALT ≤ 2.5 times ULN. vi. Total bilirubin ≤ 1.5 times ULN. vii. Serumcreatinine ≤ 1.5 times ULN.

10. Consent to Avoid Pregnancy or Causing Pregnancy Under the Following Criteria i.Female participants not of reproductive age, defined as having undergone ahysterectomy and/or bilateral oophorectomy, experiencing continuous menopause formore than 12 months, or being over 60 years of age.

ii. Female participants of reproductive age must undergo a pregnancy test and have a confirmed negative result during the preparation phase and before the first day of vaccination. They must also consent to using contraception with an efficacy rate greater than 99%, as recommended by the principal investigator, throughout the study duration, including the preparation phase and follow-up, and up to 120 days after the final treatment.

iii. Male participants must consent to using contraception with an efficacy rate greater than 99%, as recommended by the principal investigator, throughout the study duration, including the preparation phase and up to 120 days after the final treatment.

Exclusion Criteria:

1. History of hypersensitivity to peptide vaccines or related substances.

2. Autoimmune disease history.

3. Previous treatments that significantly suppress or impair immune function.

4. Refusal of current standard-of-care treatment.

5. Active brain or central nervous system metastases unless well-controlled withsteroids ≤ 10 mg/day prednisolone.

6. Presence of more than one active cancer type.

7. Uncontrolled cardiac conditions, such as unstable angina or advanced heart failure (NYHA Class III/IV). i. Participants with pacemakers may be eligible if stabilized for at least 1 monthbefore vaccination.

8. Receipt of any other vaccines within 28 days before the first neoantigen peptidevaccine.

9. Participation in another clinical trial.

10. Use of immunosuppressive drugs or steroids > 10 mg/day prednisolone (exceptinhaled/intranasal corticosteroids).

11. Pre-existing conditions that could compromise the efficacy or safety of the peptidevaccine.

12. Pregnancy or breastfeeding.