Ignite Creation Date:
2024-05-06 @ 2:30 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04337931
Status:
TERMINATED
Last Update Posted:
2024-02-13
First Post:
2020-03-30
Brief Title:
A Study to Evaluate Sotigalimab APX005M in Subjects With Unresectable or Metastatic Melanoma
Sponsor:
Apexigen America Inc
Organization:
Apexigen America Inc
Study Overview
Official Title:
A Phase II Multicenter Open-label Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody Sotigalimab APX005M With or Without Stereotactic Body Radiation Therapy in Adults With Unresectable or Metastatic Melanoma
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision not due to safety reason
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter open label Phase 2 study with 3 parallel cohorts The aim of the study is to evaluate the efficacy of sotigalimab APX005M administered at 2 different schedules to adult participants with unresectable or metastatic melanoma Participants who have not received prior immunotherapy will be alternately assigned to 1 of 2 cohorts with different sotigalimab administration schedules as long as both are open for enrollment Participants who have failed any number of prior lines of therapy will be assigned to a 3rd cohort of sotigalimab in combination with radiation therapy
Detailed Description:
This is a multicenter open label Phase 2 study with 3 parallel cohorts The aim of the study is to evaluate the efficacy of Sotigalimab administered at 2 different schedules to adult participants with unresectable or metastatic melanoma who have not received prior immunotherapy Enrolled participants will be alternately assigned to one of the following 2 cohorts groups as long as both cohorts are open
Cohort 1 APX005M administered IV at 03 mgkg every 3 weeks 21-day cycle Cohort 2 APX005M administered IV at 03 mgkg every 2 weeks 14-day cycle Sotigalimab in combination with stereotactic body radiation therapy SBRT in adults with unresectable or metastatic melanoma who have failed any number of prior lines of therapy will be assigned to Cohort 3 Sotigalimab administered IV at 03 mgkg in combination with radiation therapy every 2 weeks 14 day cycle up to 16 weeks followed by sotigalimab administered IV at 03 mgkg every 2 weeks 14-day cycle
Primary Objective
Evaluate the overall response rate ORR by RECIST 11 measurements in each of the cohorts
Secondary Objectives
Evaluate the safety of sotigalimab alone or in combination with radiation therapy in each cohort
Evaluate ORR by modified RECIST 11 for immune-based therapeutics iRECIST in each cohort
Evaluate median duration of response DOR in each cohort
Cohort 1 APX005M administered IV at 03 mgkg every 3 weeks 21-day cycle Cohort 2 APX005M administered IV at 03 mgkg every 2 weeks 14-day cycle Sotigalimab in combination with stereotactic body radiation therapy SBRT in adults with unresectable or metastatic melanoma who have failed any number of prior lines of therapy will be assigned to Cohort 3 Sotigalimab administered IV at 03 mgkg in combination with radiation therapy every 2 weeks 14 day cycle up to 16 weeks followed by sotigalimab administered IV at 03 mgkg every 2 weeks 14-day cycle
Primary Objective
Evaluate the overall response rate ORR by RECIST 11 measurements in each of the cohorts
Secondary Objectives
Evaluate the safety of sotigalimab alone or in combination with radiation therapy in each cohort
Evaluate ORR by modified RECIST 11 for immune-based therapeutics iRECIST in each cohort
Evaluate median duration of response DOR in each cohort
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