NCT06607939

ORB-021 In Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Orionis Biosciences Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to determine if an investigational new drug, named ORB-021, developed by Orionis Biosciences is safe and can be tolerated in people diagnosed with an advanced solid tumor. The study also aims to find the biologically optimal dose of the study medicine by assessing the safety and potential activity in the treatment of solid tumors. There are three phases to this study: screening, treatment and end of treatment.

Detailed description

ORB-021 is a complex engineered biologic molecule that targets cytokine activation specifically to certain immune cells which may have benefit in solid tumors. The cytokine in ORB-021 is inactive to cells expressing the receptor but confers full activity to individual cells when also bound to the target, thereby markedly reducing the potential for toxicities caused by the cytokine. ORB-021 is administered by intravenous (IV) infusion/injection.

Conditions

• Advanced Solid Tumors Cancer

Interventions

Type	Name	Description
DRUG	ORB-021	ORB-021 is dosed via IV infusion

Timeline

• Start date: 2024-11-21
• Primary completion: 2026-05-29
• Completion: 2027-05-01
• First posted: 2024-09-23
• Last updated: 2026-02-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study