Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616636
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
A Phase Ib Study of Rezatapopt in Combination with Azacitidine or Azacitidine and Venetoclax in Patients with TP53Y220C Mutant Myeloid Malignancies Acute Myeloid Leukemia or Myelodysplastic Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase Ib Study of Rezatapopt in Combination with Azacitidine or Azacitidine and Venetoclax in Patients with TP53Y220C Mutant Myeloid Malignancies Acute Myeloid Leukemia or Myelodysplastic Syndrome
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:
None
Brief Summary:
A non-randomized phase Ib study of PC14586 PMV therapeutics in patients diagnosed with TP53Y220C-mutant myeloid malignancies including AML and MDS
Detailed Description:
Primary Objective
To assess the safety and tolerability of rezatapopt in combination with AZA - VEN in patients with TP53Y220C -mutant myeloid malignancies AML MDS
Secondary Objectives
1 To determine the clinical efficacy of rezatapopt in combination with AZA - VEN in RR and newly diagnosed patients with TP53Y220C -mutant myeloid malignancies
2 To assess event free survival EFS and overall survival OS in patients receiving rezatapopt in combination with AZA - VEN
3 To assess duration of response in patients receiving rezatapopt in combination with AZA - VEN
4 Characterize the pharmacokinetics of rezatapopt in combination with AZA - VEN
Exploratory Objectives
1 To assess changes in the variant allele frequencies of TP53Y220C mutations via next-generation sequencing
2 To describe mutational profiles of patients on study at screening response and at relapse and correlate to clinical parameters
3 To assess changes in clonal architecture based on bone marrow aspirate samples using single cell sequencing
4 To evaluate for p53 activation and changes in the immunologic profile of patients of TP53Y220C mutations
To assess the safety and tolerability of rezatapopt in combination with AZA - VEN in patients with TP53Y220C -mutant myeloid malignancies AML MDS
Secondary Objectives
1 To determine the clinical efficacy of rezatapopt in combination with AZA - VEN in RR and newly diagnosed patients with TP53Y220C -mutant myeloid malignancies
2 To assess event free survival EFS and overall survival OS in patients receiving rezatapopt in combination with AZA - VEN
3 To assess duration of response in patients receiving rezatapopt in combination with AZA - VEN
4 Characterize the pharmacokinetics of rezatapopt in combination with AZA - VEN
Exploratory Objectives
1 To assess changes in the variant allele frequencies of TP53Y220C mutations via next-generation sequencing
2 To describe mutational profiles of patients on study at screening response and at relapse and correlate to clinical parameters
3 To assess changes in clonal architecture based on bone marrow aspirate samples using single cell sequencing
4 To evaluate for p53 activation and changes in the immunologic profile of patients of TP53Y220C mutations
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