NCT05947474

ORB-011 In Patients With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• 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-011, 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-011 is a complex engineered biologic molecule that targets interferon alpha 2b activation specifically to type 1 conventional dendritic cells (cDC1). The interferon alpha 2b in ORB-011 is inactive to all other cell types but confers full activation in cis when bound to cDC1 cells which exclusively express CLEC9a, thereby eliminating the potential systemic toxicities caused by alpha interferon when binding to interferon receptors on other cells. ORB-1 is administered by intravenous (IV) infusion. In cancer patients, treatment may be repeated every 3 weeks.

Conditions

• Advanced Solid Cancer

Interventions

Type	Name	Description
DRUG	ORB-011	Drug: ORB-011 is dosed via IV infusion

Timeline

• Start date: 2023-08-21
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2023-07-17
• Last updated: 2026-02-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study