Ignite Creation Date:
2024-05-06 @ 8:22 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02726334
Status:
TERMINATED
Last Update Posted:
2019-01-16
First Post:
2016-03-28
Brief Title:
A Phase I Dose Escalation Study of BNC101 in Patients With Metastatic Colorectal Cancer
Sponsor:
Bionomics Limited
Organization:
Bionomics Limited
Study Overview
Official Title:
A Phase I Dose Escalation Study of BNC101 Anti-LGR5 Humanized Monoclonal Antibody in Patients With Metastatic Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Monotherapy arm completed Combination arm did not proceed sponsor decision
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 which will be the dose recommended for a Phase 2 study safety tolerability and pharmacokinetic profile study of movement of the drug within the body including absorption and distribution of the study drug BNC101 when administered intravenously as a single agent or in combination with chemotherapy in patients with metastatic colorectal cancer who have failed at least 1 or 2 lines of chemotherapy
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