Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-01-04 @ 6:01 PM
Study NCT ID:
NCT07002203
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2025-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Neoantigen Peptide Vaccines for Solid Tumors
Sponsor:
Seqker Biosciences, Inc.
Organization:
Study Overview
Official Title:
A Phase Ib Clinical Study of Personalized Neoantigen Peptide Vaccines for Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: