Personalized Neoantigen Peptide Vaccines for Solid Tumors

Inclusion criteria

• Age: 20 years or older.
• Language proficiency: Able to read and understand Thai clearly.
• Consent: Willing to provide informed consent and sign a participation agreement.
• Life expectancy: Estimated to be at least 6 months from the date of consent.
• Eligibility from prior research: Must have participated in the SQK01-002A research project and have tumor tissue confirmed as suitable for neoantigen peptide vaccine production.
• Performance status: ECOG performance status of 0-2 with stable organ function, no rapid disease progression, or impending organ failure.
• Cancer diagnosis: Clinically and pathologically confirmed cancer diagnosis, with supporting radiological evidence.
• Cancer stage-specific criteria:

i. Advanced cancer: Suitable for immune checkpoint inhibitors (ICIs) and shows resistance to prior therapies, with measurable lesions based on mRECIST1.1 criteria.

ii. Early-stage cancer: High recurrence risk despite prior surgery and/or radiotherapy, with no current adjuvant treatment standard.

• 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. Serum creatinine ≤ 1.5 times ULN.

• Consent to Avoid Pregnancy or Causing Pregnancy Under the Following Criteria i. Female participants not of reproductive age, defined as having undergone a hysterectomy and/or bilateral oophorectomy, experiencing continuous menopause for more 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

• History of hypersensitivity to peptide vaccines or related substances.
• Autoimmune disease history.
• Previous treatments that significantly suppress or impair immune function.
• Refusal of current standard-of-care treatment.
• Active brain or central nervous system metastases unless well-controlled with steroids ≤ 10 mg/day prednisolone.
• Presence of more than one active cancer type.
• 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 month before vaccination.

• Receipt of any other vaccines within 28 days before the first neoantigen peptide vaccine.
• Participation in another clinical trial.
• Use of immunosuppressive drugs or steroids > 10 mg/day prednisolone (except inhaled/intranasal corticosteroids).
• Pre-existing conditions that could compromise the efficacy or safety of the peptide vaccine.
• Pregnancy or breastfeeding.