NCT05060432

Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors

A Multicenter, Open-Label, Phase I/II Study of EOS884448 (EOS-448) in Combination With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: iTeos Belgium SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, phase I/II basket study, evaluating the safety, tolerability, RP2D, pharmacokinetics, pharmacodynamics and antitumor activity of EOS-448 (also known as GSK4428859A or belrestotug) combined with standard of care and/or with investigational therapies in participants with advanced solid tumors.

Detailed description

The combinations evaluated will be: * EOS-448 combined with pembrolizumab, an anti-PD-1 antibody * EOS-448 combined with inupadenant an investigational adenosine A2A receptor antagonist * EOS-448 combined with dostarlimab an anti-PD-1 antibody * inupadenant combined with dostarlimab * EOS-448 combined with inupadenant and dostarlimab * EOS-448 combined with dostarlimab and standard of care chemotherapies in participants with NSCLC

Conditions

• Advanced Cancer
• Lung Cancer
• Head and Neck Cancer
• Melanoma

Interventions

Type	Name	Description
DRUG	EOS-448	Anti-TIGIT monoclonal antibody
DRUG	pembrolizumab	Anti-PD-1 monoclonal antibody
DRUG	inupadenant	A2A receptor antagonist
DRUG	Dostarlimab	Anti-PD-1 monoclonal antibody
DRUG	SOC chemotherapies	SOC chemotherapies in 1L mNSCLC

Timeline

• Start date: 2021-09-06
• Primary completion: 2024-07-01
• Completion: 2025-07-01
• First posted: 2021-09-29
• Last updated: 2024-06-21

Locations

42 sites across 6 countries: United States, Belgium, France, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study