Personalized Neoantigen Peptide Vaccines for Solid Tumors

Launched by SEQKER BIOSCIENCES, INC. · May 23, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new personalized cancer treatment called a neoantigen peptide vaccine for patients with solid tumors, which are types of cancer that form in tissues or organs. The vaccine is specially made for each patient by using unique mutations found in their own tumor. The main aim is to help the patient's immune system recognize and attack the cancer more effectively. The trial is open to adults aged 20 and older who have advanced cancers that haven't responded to previous treatments or early-stage cancers that have a high risk of coming back.

Participants in the trial will receive the personalized vaccine along with two additional treatments: a substance that boosts the immune system and a medication that helps keep the immune response active against the cancer. The treatments will be given through multiple injections over several months, and participants will be monitored for up to a year to see how well their cancer responds. To be eligible, patients must have a confirmed cancer diagnosis and meet certain health criteria, such as having stable organ function and a life expectancy of at least six months. Importantly, everyone in the trial will receive the treatment; there is no placebo group. This study is being conducted by a team of cancer specialists at Bumrungrad International Hospital in Bangkok, Thailand.

Gender

ALL

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 radiotherapy, 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. Serum creatinine ≤ 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 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:
• • 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 with steroids ≤ 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 month before vaccination.
• • 8. Receipt of any other vaccines within 28 days before the first neoantigen peptide vaccine.
• • 9. Participation in another clinical trial.
• • 10. Use of immunosuppressive drugs or steroids \> 10 mg/day prednisolone (except inhaled/intranasal corticosteroids).
• • 11. Pre-existing conditions that could compromise the efficacy or safety of the peptide vaccine.
• • 12. Pregnancy or breastfeeding.