Cancer Immunotherapy Study

Introduction

The study investigates the OX40 agonist monoclonal antibody (HFB301001) in patients with solid tumors. It focuses on the pharmacological profile and potential of T cell stimulation.

Key Eligibility Criteria

• Male/Female
• Histologically confirmed metastatic cancer
• Patients must have measurable disease
• Willing to undergo biopsies

Key Objectives

• Characterize the relationship between tumor immunogenicity and biomarkers.
• Assess the pharmacodynamic profile and safety.
• Evaluate the expansion dose and determine the recommended dose for escalation.

Study Design

This is a Phase I multicenter study initiated in February 2022 across several sites in the United States and Spain. Patients are treated with a dose escalation strategy.

Biomarker Assessment

Predictive biomarkers will be identified to enable precise treatment regimens. The trial aims to document:

• Efficacy of HFB301001 on T cell populations.
• Modulation of the immune microenvironment.

!

Enrollment

Enrollment for this trial opened in February 2022. The participating sites include:

• USC Norris Comprehensive Cancer Center, Los Angeles, CA
• Mayo Clinic, Jacksonville, FL
• Virginia Cancer Specialists, Fairfax, VA

References

1. Glisson et al. Clin Cancer Res. 2020;26(20):5358-5367
2. Kim et al. Clin Cancer Res. 2022; clincanres.4020.2021
3. Postel-Vinay et al. Cancer Res 2020; 80 (16_Supplement):CT150
4. Diab et al. Clin Cancer Res. 2022; 28(1): 71-83
5. AACR 2020, E-Poster #2285
6. Guo et al. Contemp Clin Trials. 2017;58:23-33

Acknowledgements

We thank the patients, families, and site investigators for their participation. Special thanks to Dr. Anthony El-Khoueiry for his presentation and support from HiFiBiO Inc.

Contact Information

Corresponding Author: elkhouei@med.usc.edu
Clinicaltrials.gov Identifier: NCT05229601
This poster was presented at the 2022 ESMO Congress (Sept 9-13, 2022); Paris, France.