About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Personalized Neoantigen Peptide Vaccine
Treatment groups
Sponsors and collaborators
Seqker Biosciences, Inc.
Lead sponsor
Bumrungrad International Hospital
Collaborator