Actively Recruiting
Personalized Neoantigen Peptide Vaccines for Solid Tumors
Led by Seqker Biosciences, Inc. · Updated on 2025-12-01
10
Participants Needed
2
Research Sites
178 weeks
Total Duration
On this page
Sponsors
S
Seqker Biosciences, Inc.
Lead Sponsor
B
Bumrungrad International Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Personalized Neoantigen Peptide Vaccines for Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or older
- Able to read and understand Thai clearly
- Willing to provide informed consent and sign participation agreement
- Estimated life expectancy of at least 6 months from consent date
- Participation in SQK01-002A project with tumor tissue suitable for neoantigen vaccine production
- ECOG performance status 0-2 with stable organ function, no rapid disease progression or impending organ failure
- Clinically and pathologically confirmed cancer diagnosis with radiological evidence
- Advanced cancer suitable for immune checkpoint inhibitors and resistant to prior therapies with measurable lesions per mRECIST1.1
- Early-stage cancer with high recurrence risk despite prior surgery and/or radiotherapy and no current adjuvant treatment standard
- Laboratory parameters: lymphocyte count ≥ 800 cells/μL, neutrophil count ≥ 1,500 cells/μL, platelet count ≥ 75,000 cells/μL, AST ≤ 2.5 times ULN, ALT ≤ 2.5 times ULN, total bilirubin ≤ 1.5 times ULN, serum creatinine ≤ 1.5 times ULN
- Female participants not of reproductive age (hysterectomy and/or bilateral oophorectomy, menopause >12 months, or over 60 years old) or if of reproductive age must have negative pregnancy test before vaccination and agree to use contraception with >99% efficacy during study and up to 120 days after final treatment
- Male participants must agree to use contraception with >99% efficacy during study and up to 120 days after final treatment
You will not qualify if you...
- History of hypersensitivity to peptide vaccines or related substances
- History of autoimmune disease
- Previous treatments causing significant immune suppression or impairment
- Refusal of current standard-of-care treatment
- Active brain or central nervous system metastases unless well-controlled with ≤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); pacemaker patients eligible if stabilized for at least 1 month
- Receipt of any other vaccines within 28 days before 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 vaccine efficacy or safety
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Horizon Cancer Excellence Center, Bumrungrad International Hospital
Bangkok, Thailand, 10110
Actively Recruiting
2
Phyathai-1 Hospital
Bangkok, Thailand, 10400
Actively Recruiting
Research Team
S
Seqker Clinical Study Team
CONTACT
T
Trairak Pisitkun, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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