Personalized neoantigen peptide vaccine for solid tumors

A Phase Ib Clinical Study of Personalized Neoantigen Peptide Vaccines for Solid Tumors

This trial will test whether a custom neoantigen peptide vaccine given with poly-ICLC and an anti-PD-1 drug can help the immune system fight solid tumors in adults with advanced or high-risk disease.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Seqker Biosciences, Inc. (industry)
• Locations: 2 sites (Bangkok and 1 other locations)
• Trial ID: NCT07002203 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults (≥20) who read Thai, previously enrolled in SQK01-002A with tumor tissue suitable for vaccine manufacture, have ECOG 0–2 and ≥6 months expected survival, and either advanced, treatment‑resistant disease or early‑stage cancer at high risk of recurrence.

Not a fit: Patients with rapid clinical progression, impending organ failure, unavailable or unsuitable tumor tissue for neoantigen design, or inability to meet the Thai-language or site attendance requirements are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the personalized vaccine approach could help a patient’s immune system better recognize and control their tumor, potentially improving disease control.

How similar studies have performed: Prior early-phase neoantigen vaccine studies have produced strong immune responses and occasional tumor regressions, though definitive survival benefits have not yet been established.

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.

Where this trial is running

Bangkok and 1 other locations

• Horizon Cancer Excellence Center, Bumrungrad International Hospital — Bangkok, Thailand (RECRUITING)
• Phyathai-1 Hospital — Bangkok, Thailand (RECRUITING)

Study contacts

• Study coordinator: Seqker Clinical Study Team

Conditions: Solid Tumors, Advanced Cancer, Recurrent Cancer, Neoantigen-Specific Immunotherapy, Personalized Cancer Vaccine