Personalized Neoantigen Peptide Vaccines for Solid Tumors

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.

NCT Number	NCT07002203
Lead Sponsor	Seqker Biosciences, Inc. Collaborators: Bumrungrad International Hospital
Conditions	Solid Tumors, Advanced Cancer, Recurrent Cancer, Neoantigen-Specific Immunotherapy, Personalized Cancer Vaccine
Enrollment	10 participants
Start Date	2024-03-01
Primary Completion	2027-08 (estimated)
Study Completion	2027-08 (estimated)
Updated on ClinicalTrials.gov	2026-07-24