Ignite Creation Date:
2024-05-06 @ 9:26 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02988817
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2016-12-01
Brief Title:
Enapotamab Vedotin HuMax-AXL-ADC Safety Study in Patients With Solid Tumors
Sponsor:
Genmab
Organization:
Genmab
Study Overview
Official Title:
First-in-human Open-label Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of Axl-specific Antibody-drug Conjugate Enapotamab Vedotin HuMax-AXL-ADC in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2023-07
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:
The purpose of the trial is to determine the maximum tolerated dose and to establish the safety profile of HuMax-AXL-ADC in a mixed population of patients with specified solid tumors
Detailed Description:
The trial consists of two parts a dose escalation part phase I first in-human FIH and an expansion part phase IIa
The dose escalation part has 2 dosing schedules 1 dose every 3 weeks 1Q3W dose regimen and 3 doses every 4 weeks 3Q4W dosing regimen
The Expansion part of the trial will further explore the recommended phase 2 dose and dosing regimens of HuMax-AXL-ADC as determined in dose escalation part
The dose escalation part has 2 dosing schedules 1 dose every 3 weeks 1Q3W dose regimen and 3 doses every 4 weeks 3Q4W dosing regimen
The Expansion part of the trial will further explore the recommended phase 2 dose and dosing regimens of HuMax-AXL-ADC as determined in dose escalation part
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-002243-42 | EUDRACT_NUMBER | None | None |
| 211258 | OTHER | IRAS ID UK Research Summaries Database | None |