Ignite Creation Date:
2024-05-06 @ 7:09 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02482168
Status:
COMPLETED
Last Update Posted:
2023-12-20
First Post:
2015-06-11
Brief Title:
Study of the CD40 Agonistic Monoclonal Antibody APX005M
Sponsor:
Apexigen America Inc
Organization:
Apexigen America Inc
Study Overview
Official Title:
Phase 1 Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Subjects With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2023-12
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:
This study is a phase 1 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M in adults with solid tumors Study is intended to establish the maximum tolerated dose and the overall safety and tolerability of APX005M in 3 different administration schedules
Detailed Description:
APX005M-001 is an open-label study and comprises a dose-escalation portion of approximately 8 dose level cohorts plus an expansion cohort
Eligible subjects with solid tumors will receive intravenous APX005M every 3 week every 2 week or every 1 week until disease progression unacceptable toxicity or death whichever occurs first
Study objectives include
Evaluate safety of APX005M
Determine the maximum tolerated dose of APX005M
Determine the pharmacokinetic parameters of APX005M the maximal drug concentration Cmax area under the curve of serum concentration over time Area Under the Curve AUC and half-life t½
Preliminary assessment of clinical response
Eligible subjects with solid tumors will receive intravenous APX005M every 3 week every 2 week or every 1 week until disease progression unacceptable toxicity or death whichever occurs first
Study objectives include
Evaluate safety of APX005M
Determine the maximum tolerated dose of APX005M
Determine the pharmacokinetic parameters of APX005M the maximal drug concentration Cmax area under the curve of serum concentration over time Area Under the Curve AUC and half-life t½
Preliminary assessment of clinical response
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