Ignite Creation Date:
2024-05-06 @ 12:55 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03886831
Status:
COMPLETED
Last Update Posted:
2023-03-28
First Post:
2019-03-08
Brief Title:
A Study of PRT543 in Participants With Advanced Solid Tumors and Hematologic Malignancies
Sponsor:
Prelude Therapeutics
Organization:
Prelude Therapeutics
Study Overview
Official Title:
A Phase 1 Open-Label Multicenter Dose Escalation Dose Expansion Study of PRT543 in Patients With Advanced Solid Tumors and Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2023-03
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 cohort dose-escalation dose-expansion study of PRT543 in patients with advanced cancers 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 PRT543
Detailed Description:
This is a multicenter open-label sequential-cohort dose-escalation dose-expansion Phase 1 study of PRT543 in patients with advanced cancers who have exhausted available treatment options Enrollment will take place concurrently into two distinct patient groups one for solid tumorslymphomas and one for hematological malignancies The study will consist of 2 parts a dose escalation part and once the recommended phase 2 dose RP2D has been determined a cohort expansion part involving up to ten separate cohorts For patients 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 PRT543
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