Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359002
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-03-26
Brief Title:
Safety Pharmacokinetics and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms
Sponsor:
Byondis BV
Organization:
Byondis BV
Study Overview
Official Title:
A First-in-human Dose Escalation and Expansion Trial With the Antibody-drug Conjugate BYON4413 to Evaluate Safety Pharmacokinetics and Preliminary Efficacy in Patients With RelapsedRefractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
Status:
RECRUITING
Status Verified Date:
2024-10
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 the first-in-human trial with BYON4413 to evaluate safety PK immunogenicity and anti-leukemia activity of BYON4413 in patients with AML or MDS
Detailed Description:
This trial includes two parts Part 1 is a dose escalation study in which the maximum tolerated dose and recommended dose for expansion of BYON4413 will be determined Part 2 is an expansion study to evaluate the anti-leukemia activity and safety of BYON4413
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-507781-13-00 | CTIS | None | None |