NCT07002203

Personalized Neoantigen Peptide Vaccines for Solid Tumors

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Seqker Biosciences, Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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 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

• Solid Tumors
• Advanced Cancer
• Recurrent Cancer
• Neoantigen-Specific Immunotherapy
• Personalized Cancer Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Personalized Neoantigen Peptide Vaccine	This is a personalized cancer vaccine made of 10-20 synthetic long peptides derived from the unique mutations (neoantigens) found in a patient's tumor. Each vaccine is custom-formulated based on whole exome and RNA sequencing of tumor and normal tissue. The peptides are administered intramuscularly in combination with poly-ICLC (Hiltonol) as an adjuvant to enhance immune response. The intervention aims to induce T-cell responses against tumor-specific neoantigens. Vaccinations are given during priming and booster phases, with long-term follow-up and immune monitoring.

Timeline

• Start date: 2024-03-01
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2025-06-03
• Last updated: 2025-12-01

Locations

2 sites across 1 country: Thailand