NCT03760952

Human Leukocyte Antigen Typing and Tumor Antigen Expression Profiling

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 242 (actual)
• Sponsor: Immatics US, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This screening study will identify HLA molecular subtype positive and tumor antigen target(s) positive patients who may be eligible for enrollment into Immatics clinical studies. This screening study is intended for patients with advanced and/or metastatic solid cancers. No treatment intervention will occur as part of this screening study.

Detailed description

The purpose of this screening study is to identify human leukocyte antigen (HLA) molecular subtype positive and tumor antigen target(s) positive patients. No treatment intervention will occur as part of this screening study. After diagnosis of advanced and/or solid metastatic cancers, patients will be tested for HLA molecular subtype positivity. Patients that are HLA molecular subtype positive are then assessed to determine if their tumor antigen target(s) is positive (biopsy screening). Fresh tumor tissue obtained by a biopsy for this screening study will be required. If the patient is undergoing a surgical procedure directed towards tumor or palliative treatment (e.g., a resection, debulking surgery, etc.) and has consented to the study, then fresh tissue may be collected during the procedure to avoid the patient being subjected to another biopsy. Tumor antigen targets in fresh tumor samples will be determined by an in vitro diagnostic (IVD) assay. Therefore, any remaining tumor specimens may be used for exploratory biomarker analyses and validation studies for regulatory approval. Immatics is conducting clinical studies which target patients with advanced and/or metastatic solid cancers. Patients who are HLA subtype phenotype positive and whose tumors express one or more of the tumor antigen targets of interest may be eligible for ongoing clinical studies of adoptive cell therapy (ACT).

Conditions

• Refractory Cancer
• Recurrent Cancer
• Adult Solid Tumor
• Neoplasms

Timeline

• Start date: 2019-02-26
• Primary completion: 2022-11-15
• Completion: 2022-11-15
• First posted: 2018-12-03
• Last updated: 2025-02-04

Locations

4 sites across 1 country: United States