NCT06614140

Personalized Neoantigen Cancer Vaccine for Patients with Solid Tumors

Active, enrolled Phase 1, PHASE2 Last updated 26 September 2024

What this trial tests

Phase 1, PHASE2 trial testing Personalized Neoantigen Peptide Vaccine with Poly-ICLC and Checkpoint Inhibitors in Cancer in 8 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

24 November 2022

Primary endpoint
15 August 2025

15 August 2025

Quick facts

Lead sponsor	Seqker Biosciences, Inc.
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	24 November 2022
Primary completion	15 August 2025
Estimated completion	15 August 2025
Sites	1 location across Thailand

Drugs / interventions tested

• Personalized Neoantigen Peptide Vaccine with Poly-ICLC and Checkpoint Inhibitors — full drug profile →

Conditions studied

• Cancer — all drugs for Cancer →
• Solid Tumor, Adult — all drugs for Solid Tumor, Adult →

Sponsor

Seqker Biosciences, Inc. — full company profile →

Who can join

18 and older, any sex, with Cancer or Solid Tumor, Adult. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This clinical trial aims to evaluate the safety, immunogenicity, and preliminary efficacy of a personalized neoantigen peptide vaccine in patients with advanced cancer or at high risk of recurrence. The study is designed for patients whose tumors have specific mutations identifiable through genomic sequencing. These mutations, known as neoantigens, are unique to each patient's cancer and serve as the target for the personalized vaccine.

Eligible patients will undergo genomic analysis, including whole exome sequencing and RNA sequencing, to identify these neoantigens. A custom peptide vaccine will then be produced and formulated to target these neoantigens. The trial consists of a preparation phase, a treatment phase with priming and booster vaccinations, and a follow-up/maintenance period of one year. The study will assess immune responses, clinical efficacy, and potential toxicities. By leveraging the immune system's ability to recognize and attack cancer cells, this vaccine aims to provide a new treatment option for patients with limited alternatives.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neoantigen-driven personalized tumor therapy: An update from discovery to clinical application.
   Xie N, Shen G, Huang C, Zhu H. · · 2025 · cited 2× · PMID 40757404 · DOI 10.1097/cm9.0000000000003708
2. Immune Surveillance and Immune Escape in Cancer: Mechanisms and Immunotherapy.
   Peng Y, Zhan L, Shi J, Wang J, et al · · 2025 · PMID 41079643 · DOI 10.1002/mco2.70321
3. Comparison of Current Immunotherapy Approaches and Novel Anti-Cancer Vaccine Modalities for Clinical Application.
   Meade E, Garvey M. · · 2025 · PMID 40943226 · DOI 10.3390/ijms26178307
4. Personalized Cancer Vaccines in the Clinical Trial Pipeline.
   Iamukova L, Alferova E. · · 2026 · PMID 40846676 · DOI 10.1111/ajco.70006