Ignite Creation Date:
2024-05-06 @ 7:14 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02499224
Status:
COMPLETED
Last Update Posted:
2021-05-13
First Post:
2015-05-14
Brief Title:
Safety and Pharmacokinetics Study of YYB101 in Advanced Solid Tumors Patients Who Are Refractory to Standard Therapy
Sponsor:
CellabMED
Organization:
CellabMED
Study Overview
Official Title:
A Phase I Study to Assess the Safety Tolerability and Pharmacokinetics of YYB101 Hepatocyte Growth Factor HGF-Neutralizing Humanized Monoclonal Antibody Mab in Advanced Solid Tumors Patients Who Are Refractory to Standard Therapy
Status:
COMPLETED
Status Verified Date:
2016-03
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 this study is to evaluate the safety tolerability pharmacokinetics and maximum tolerated dose MTD of YYB101 HGF-neutralizing humanized Mab in advanced solid tumors patients who are refractory to standard therapy
Detailed Description:
To evaluate the safety tolerability and pharmacokinetics of YYB101 patients who are refractory to standard therapy will be enrolled in this study In dose-escalation cohort subjects will be enrolled sequentially into four dose cohorts receiving a single dose of YYB101 03 1 3 or 5 mgkg 3 or 6 subjects per dose cohort and will be entered the 4-week treatment-free period to evaluate safety and pharmacokinetics If no dose-limiting toxicity DLT is observed during the 4-week period YYB101 administration will be resumed at the same dose level every 2 weeks until disease progression or unacceptable toxicity development After the completion of the dose-escalation cohort additional subjects will be enrolled into a dose-expansion cohort at the maximum tolerated dose MTD or recommended phase II dose RP2D for further exploration of safety tolerability efficacy and pharmacodynamics
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