Ignite Creation Date:
2025-12-18 @ 8:21 AM
Ignite Modification Date:
2025-12-23 @ 9:50 PM
Study NCT ID:
NCT02001623
Status:
None
Last Update Posted:
2021-12-29 00:00:00
First Post:
2013-11-14 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors
Sponsor:
None
Organization:
Study Overview
Official Title:
First-in-human, Dose-escalating Safety Study of Tissue Factor Specific Antibody Drug Conjugate Tisotumab Vedotin (HuMax® TF ADC) in Patients With Locally Advanced and/or Metastatic Solid Tumors Known to Express Tissue Factor
Status:
None
Status Verified Date:
2021-11
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 study is conducted in two parts. The dose escalation portion of the trial subjects are enrolled into cohorts at increasing dose levels of HuMax-TF-ADC in 21 day treatment cycles.
In the Cohort Expansion part of the trial, will further explore the recommended phase 2 dose of HuMax-TF-ADC as determined in Part 1
In the Cohort Expansion part of the trial, will further explore the recommended phase 2 dose of HuMax-TF-ADC as determined in Part 1
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?: