Ignite Creation Date:
2024-05-06 @ 9:58 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03123783
Status:
COMPLETED
Last Update Posted:
2023-12-26
First Post:
2017-04-17
Brief Title:
CD40 Agonistic Antibody APX005M Sotigalimab in Combination With Nivolumab
Sponsor:
Apexigen America Inc
Organization:
Apexigen America Inc
Study Overview
Official Title:
A Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody APX005M Administered in Combination With Nivolumab in Subjects With Non-small Cell Lung Cancer and Subjects With Metastatic Melanoma
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 1-2 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M administered in combination with nivolumab to adult subjects with non-small cell lung cancer or metastatic melanoma The Phase 1 portion is intended to establish the maximum tolerated dose and the recommended phase 2 dose of APX005M when administered in combination with nivolumab The Phase 2 portion of the study will evaluate safety and efficacy of the combination
Detailed Description:
APX005M-002 is an open-label Phase 1-2 study and comprises a dose-escalation portion Phase 1 followed by a Phase 2 tumor specific portion
Eligible subjects with non-small cell lung cancer or metastatic melanoma will receive intravenous APX005M in combination with nivolumab until disease progression unacceptable toxicity or death whichever occurs first
Study objectives include
Determine the maximum tolerated dose and the recommended phase 2 dose of APX005M when given in combination with nivolumab
Evaluate safety of the APX005M and nivolumab combination
Evaluate the objective response rate duration of response and median PFS by RECIST 11 in subjects with non-small cell lung cancer or metastatic melanoma receiving APX005M in combination with nivolumab
Determine the PK of APX005M
Eligible subjects with non-small cell lung cancer or metastatic melanoma will receive intravenous APX005M in combination with nivolumab until disease progression unacceptable toxicity or death whichever occurs first
Study objectives include
Determine the maximum tolerated dose and the recommended phase 2 dose of APX005M when given in combination with nivolumab
Evaluate safety of the APX005M and nivolumab combination
Evaluate the objective response rate duration of response and median PFS by RECIST 11 in subjects with non-small cell lung cancer or metastatic melanoma receiving APX005M in combination with nivolumab
Determine the PK of APX005M
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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