Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481936
Status:
TERMINATED
Last Update Posted:
2023-03-23
First Post:
2007-05-31
Brief Title:
Study of the Safety of VB6-845 in Patients With Advanced Solid Tumours of Epithelial Origin
Sponsor:
Sesen Bio Inc
Organization:
Sesen Bio Inc
Study Overview
Official Title:
A Phase I Escalating Dose Study of VB6-845 a Recombinant Fusion Protein Targeting EpCAM in Patients With Advanced Solid Tumours of Epithelial Origin
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Corporate reasons unrelated to safety and efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the maximum tolerated dose MTD of VB6-845 and to evaluate the safety and tolerability of VB6-845 when administered as a monotherapy IV infusion to patients with advanced solid tumour of epithelial origin
Detailed Description:
The primary study objective of this Phase 1 trial was to determine the maximum tolerated dose MTD of VB6-845 and evaluate the safety and tolerability of VB6-845 when administered as a monotherapy intravenous IV infusion over 3 hours once weekly in 4-week cycles to subjects with EpCAM positive advanced solid tumours of epithelial origin
Secondary objectives included evaluating the pharmacokinetic profile and immunogenicity of VB6-845 and assessing exploratory efficacy of VB6-845
Dose cohorts of 3-6 subjects with EpCAM positive advanced solid tumours of epithelial origin are to be entered into the study The starting dose is defined as 100 mgkg which is 110 of the no observed adverse effect level NOAEL reached in preclinical studies Doses are to be escalated according to the modified Fibonacci design until 2 out of 3 or 2 out of 6 subjects experienced a Dose Limiting Toxicity DLT The MTD is to be reached when 2 out of 6 subjects experienced a DLT An additional 12 subjects are to be enrolled at the MTD for further characterization of VB6-845 at that level
Regardless of dose cohort subjects are to continue to receive treatment until an unacceptable toxicity occurred all lesions completely disappeared or disease progression is determined
Secondary objectives included evaluating the pharmacokinetic profile and immunogenicity of VB6-845 and assessing exploratory efficacy of VB6-845
Dose cohorts of 3-6 subjects with EpCAM positive advanced solid tumours of epithelial origin are to be entered into the study The starting dose is defined as 100 mgkg which is 110 of the no observed adverse effect level NOAEL reached in preclinical studies Doses are to be escalated according to the modified Fibonacci design until 2 out of 3 or 2 out of 6 subjects experienced a Dose Limiting Toxicity DLT The MTD is to be reached when 2 out of 6 subjects experienced a DLT An additional 12 subjects are to be enrolled at the MTD for further characterization of VB6-845 at that level
Regardless of dose cohort subjects are to continue to receive treatment until an unacceptable toxicity occurred all lesions completely disappeared or disease progression is determined
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