Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05829226
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2023-03-30
Brief Title:
A Phase 1 Study With LYT-200 in Patients With RelapsedRefractory Acute Myeloid Leukemia AML or With RelapsedRefractory High-risk Myelodysplastic Syndrome MDS
Sponsor:
PureTech
Organization:
PureTech
Study Overview
Official Title:
A Phase 1 Open-label Multi-center Study of the Safety Pharmacokinetics PK and Anti-tumor Activity of LYT- 200 in Patients With RelapsedRefractory Acute Myeloid Leukemia AML or With RelapsedRefractory High-risk Myelodysplastic Syndrome MDS
Status:
RECRUITING
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:
A Phase 1 Open-label Multi-center Study of the Safety Pharmacokinetics PK and Anti-tumor Activity of LYT- 200 in Patients with RelapsedRefractory Acute Myeloid Leukemia AML or with Relapsedrefractory High-risk Myelodysplastic Syndrome MDS
Detailed Description:
This is an open-label non-randomized multi-center Phase 1 dose escalation study in patients with AML relapsedrefractory to at least one line of prior therapy with or without an allogeneic stem cell transplant or in patients with a documented diagnosis of relapsedrefractory high-risk myelodysplastic syndrome MDS post at least one line of treatment and for whom no standard therapy that may provide clinical benefit is available The 42 algorithm-based dose-escalation design will be used to help identify the recommended Phase 2 dose RP2D Single agent LYT-200 and in combination with venetoclax andor hypomethylating agents HMA safety and tolerability evaluation is the primary study endpoint Pharmacokinetics PK and Anti-tumor Activity of LYT- 200 single agent and in combination with venetoclax andor HMAs are key secondary study endpoints
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