Personalized Neoantigen Peptide Vaccines for Solid Tumors
Trial Parameters
Brief Summary
This clinical trial is studying the safety and efficacy of a personalized cancer vaccine called a neoantigen peptide vaccine in patients with solid tumors. These vaccines are custom-made for each patient using specific mutations (neoantigens) found in their own tumor. The goal is to help the patient's immune system recognize and attack their cancer. The study will enroll adult patients (20 years or older) who have solid tumors that meet specific stage-related criteria. These include advanced cancers that are resistant to prior treatments and early-stage cancers at high risk of recurrence, where there are no standard adjuvant therapies available. Participants will receive: * A personalized neoantigen peptide vaccine designed from the mutations in their tumor tissue. * Poly-ICLC (Hiltonol), a substance that stimulates the immune system. * An anti-PD-1 immune checkpoint inhibitor, a drug that helps the immune system stay active against cancer. The vaccine and drugs will be given through multiple injections over several months. Blood samples and imaging will be used to monitor the immune response and how the cancer responds to treatment. Participants will be followed for up to 12 months. This study does not include a placebo group. Every participant will receive the personalized vaccine along with the other therapies. The primary objectives of this study are: 1. To assess whether the treatment is safe and tolerable. 2. To evaluate whether this approach helps control the cancer and can be combined with other standard treatments in the future.
Eligibility Criteria
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 research project and have tumor tissue confirmed as suitable for neoantigen peptide vaccine production. 6. Performance status: ECOG performance status of 0-2 with stable organ function, no rapid disease progression, or impending organ failure. 7. Cancer diagnosis: Clinically and pathologically confirmed cancer diagnosis, with supporting radiological evidence. 8. 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 radiothera