Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413680
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-09
Brief Title:
A First-In Human FIH Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Phase 12a Open-Label Dose-Escalation and Dose-Expansion First-In-Human Study of the Safety Tolerability Activity and Pharmacokinetics of REGN10597 Anti PD-1-IL2RA-IL2 Fusion Protein in Patients With Advanced Solid Organ Malignancies
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is researching an experimental drug called REGN10597 called study drug The study is focused on patients with certain solid tumors that are in an advanced stage
The aim of the study is to see how safe tolerable and effective the study drug is
The study is looking at several other research questions including
What side effects may happen from taking the study drug
How much study drug is in the blood at different times
Whether the body makes antibodies against the study drug which could make the drug less effective or could lead to side effects
The aim of the study is to see how safe tolerable and effective the study drug is
The study is looking at several other research questions including
What side effects may happen from taking the study drug
How much study drug is in the blood at different times
Whether the body makes antibodies against the study drug which could make the drug less effective or could lead to side effects
Detailed Description:
Phase 1 Conducted in the United States Phase 2 Conducted globally
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None