Personalized neoantigen peptide vaccine for solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1/2 protocol manufactures a personalized peptide vaccine from each patient’s tumor mutations and administers it together with the immune stimulant poly-ICLC and an anti-PD-1 checkpoint inhibitor. Eligible adults (≥20 years) must previously have participated in SQK01-002A and have tumor tissue confirmed suitable for vaccine production, an ECOG performance status of 0–2, and an expected survival of at least six months. The study tracks safety, neoantigen-specific immune responses, and clinical tumor outcomes using standard imaging and response criteria over scheduled visits. Treatment and follow-up occur at participating Bangkok centers with serial blood draws and clinic assessments to monitor side effects and signals of benefit.

Why it matters

Who can join: the full rules

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.

Where it's running

• Horizon Cancer Excellence Center, Bumrungrad International Hospital
  Bangkok, Thailand Recruiting

Study contacts

• Study coordinator: Seqker Clinical Study Team
• Email: clinical@seqker.com
• Phone: +6690-986-2498

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treatment of advanced solid tumors with APL-101 for specific genetic mutations

  This study is testing a new oral medication called APL-101 to see if it helps people with advanced lung cancer and other solid tumors that have certain genetic changes, especially those who haven't had success with standard treatments.

  Recruiting at 32 sites Phase 2 Apollomics Inc. · Los Angeles, California and 34 other locations · NCT03175224

• BA1203 in advanced solid tumors: safety and early signs of activity

  This early-phase trial tests BA1203 in adults with advanced solid tumors to see if it is safe, tolerable, how the drug behaves in the body, and whether it shows any early signs of effectiveness.

  Recruiting Phase 1 Shandong Boan Biotechnology Co., Ltd · Beijing · NCT07876609

• BL-M08D treatment in melanoma and other solid tumors

  A phase Ib/II study tests BL-M08D1 injections in adults with locally advanced or metastatic melanoma and other solid tumors to see if it is safe and helpful.

  Recruiting Phase 1/2 Sichuan Baili Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT07841925

• REC-7735 for PIK3CA-H1047R-mutant solid tumors

  This study tests REC-7735 in people with unresectable, locally advanced, or metastatic solid tumors that carry the PIK3CA-H1047R mutation.

  Recruiting at 3 sites Phase 1/2 Recursion Pharmaceuticals Inc. · Grand Rapids, Michigan and 2 other locations · NCT07819136

• Preferences of physicians and patients for cell therapies in advanced solid tumors

  This study tests how doctors and patients weigh the benefits, risks, and burdens of CAR-T, TIL, TCR-T, and NK cell therapies in advanced solid cancers.

  Recruiting Zhejiang University · Hangzhou, Zhejiang · NCT07813000

• HP007 monotherapy for relapsed or advanced solid tumors

  This study tests HP007 as a standalone treatment in adults with hard-to-treat solid tumors to see if it is safe and tolerable and to look for early signs of activity.

  Recruiting Phase 1 Parr Biotechnology (Hebei) Co., Ltd. · Changchun, Jilin · NCT07800936

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.