Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563804
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
A Study to Evaluate S227928 as a Single Agent and in Combination With Venetoclax in Patients With RR AML MDSAML or CMML
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 12 Clinical Trial of S227928 an Anti-CD74 Antibody-Drug Conjugate Targeting MCL-1 as a Single Agent and in Combination With Venetoclax in Patients With RelapsedRefractory RR Acute Myeloid Leukemia AML Myelodysplastic Syndrome MDSAML or Chronic Myelomonocytic Leukemia CMML
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
The objective of this study is to determine the safety tolerability and anti-leukemic activity of S227928 as single agent and in combination with venetoclax and to determine the recommended Phase 2 dose RP2D of this combination The study will begin as a Phase 1 Dose Escalation study to determine the RP2D and then will transition to a Phase 2 Dose Expansion study to assess the efficacy of the selected RP2D During the treatment period participants will have study visits every two weeks with additional visits occurring during the first and second cycle Approximately 30 days after treatment has ended an end-of-treatment visit will occur and then participants will be followed for survival every 12 weeks for the next 6 months Study visits may include a bone marrow aspirate andor biopsy blood and urine tests ECG vital signs physical examination and administration of study treatment
Detailed Description:
None
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