NCT05158621

A Screening Study Targeting Tumor-specific Antigens

A Screening Study for the Selection of Patients for Clinical Studies Targeting Tumor-specific Antigens

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: Gritstone bio, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to identify patients who may be eligible to participate in a separate Phase 2/3 treatment study evaluating an individualized neoantigen vaccine GRANITE for first line (1L) maintenance treatment of metastatic, microsatellite-sable colorectal cancer (MSS-CRC) sponsored by Gritstone bio. This may include the manufacturing of an individualized vaccine, which involves neoantigen prediction and generating a vaccine targeting neoantigens.

Detailed description

The screening study can enroll multiple tumor types in multiple treatment settings for the potential inclusion in a treatment study. Patient's tumors are analyzed to determine if the patient's tumor contains sufficient mutations. This screening study is currently enrolling patients with localized colon cancer or metastatic colorectal cancer for the development of an individualized neoantigen-based cancer vaccine that requires a manufacturing period for each patient. The process of generating an individualized neoantigen cancer vaccine involves multiple steps, including collection of patient tumor and blood specimens, performing next-generation sequencing (NGS), predicting the neoantigens to be included in the individualized vaccine, and the manufacture and release of the individualized vaccine. Study participants will not receive any investigational treatment as part of this trial. Patients screened in this study may be able to enroll in a separate investigational treatment study sponsored by Gritstone bio, provided that the patient meets the specified eligibility criteria for that treatment study.

Conditions

• Metastatic Colorectal Cancer
• Stage II/III Colon Cancer

Interventions

Type	Name	Description
PROCEDURE	blood collection for research (next generation sequencing [NGS])	participants will have whole blood collected for NGS
PROCEDURE	blood collection for research (HLA typing)	participants will have whole blood collected for HLA typing
PROCEDURE	blood collection for research (circulating tumor DNA [ctDNA])	participants will have whole blood collected for ctDNA detection

Timeline

• Start date: 2021-12-14
• Primary completion: 2022-08-15
• Completion: 2022-08-15
• First posted: 2021-12-15
• Last updated: 2022-10-18

Locations

6 sites across 1 country: United States