Status:
RECRUITING
Personalized Neoantigen Peptide Vaccines for Solid Tumors
Lead Sponsor:
Seqker Biosciences, Inc.
Collaborating Sponsors:
Bumrungrad International Hospital
Conditions:
Solid Tumors
Advanced Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE1
PHASE2
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 pati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07002203
Start Date
March 1 2024
End Date
August 1 2027
Last Update
December 1 2025
Active Locations (2)
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1
Horizon Cancer Excellence Center, Bumrungrad International Hospital
Bangkok, Thailand, 10110
2
Phyathai-1 Hospital
Bangkok, Thailand, 10400