Ignite Creation Date:
2024-05-06 @ 1:40 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04089449
Status:
COMPLETED
Last Update Posted:
2023-04-05
First Post:
2019-09-11
Brief Title:
A Study of PRT811 in Participants With Advanced Solid Tumors CNS Lymphoma and Gliomas
Sponsor:
Prelude Therapeutics
Organization:
Prelude Therapeutics
Study Overview
Official Title:
A Phase 1 Open-Label Multicenter Dose Escalation and Expansion Study of PRT811 in Subjects With Advanced Solid Tumors CNS Lymphoma and Recurrent High-Grade Gliomas
Status:
COMPLETED
Status Verified Date:
2023-04
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 is a Phase 1 dose-escalation study of PRT811 a protein arginine N-methyltransferase PRMT 5 inhibitor in subjects with advanced cancers and high-grade gliomas who have exhausted available treatment options The purpose of this study is to define a safe dose and schedule to be used in subsequent development of PRT811
Detailed Description:
This is a multicenter open-label dose-escalation dose-expansion Phase 1 study of PRT811 a PRMT5 inhibitor in subjects with advanced cancers without any approved or available treatment options including solid tumors CNS lymphoma and or high-grade gliomas The study will consist of 2 parts a dose escalation part evaluating subjects with advanced solid tumors CNS lymphoma andor high-grade glioma and a cohort expansion part which will evaluate the safety and efficacy of PRT811 in subjects with advanced solid tumors and glioblastoma multiforme For subjects the study will include a screening phase a treatment phase and a post treatment follow-up phase An end-of-study visit will be conducted within 30 days after the last dose of PRT811
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