Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607939
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
ORB-021 In Patients With Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ORB-021 In Patients With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OR2-01
Brief 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
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 infusioninjection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None