Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06060613
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2023-09-22
Brief Title:
Safety and Efficacy of OBX-115 in Advanced Solid Tumors
Sponsor:
Obsidian Therapeutics Inc
Organization:
Obsidian Therapeutics Inc
Study Overview
Official Title:
A Phase 12 Open-Label Study to Investigate the Safety and Efficacy of Membrane Bound IL15 Expressing Tumor-Infiltrating Lymphocytes OBX-115 in Participants with Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Agni-01
Brief Summary:
This is a study to investigate the safety and efficacy of an investigational OBX-115 regimen in adult participants with advanced solid tumors
Detailed Description:
Primary Objective Phase 1
Assess the safety and tolerability of OBX-115 regimen
Primary Objective Phase 2
Evaluate preliminary efficacy of OBX-115 regimen as measured by the investigator using objective response rate ORR per Response Evaluation Criteria in Solid Tumors RECIST v11
Secondary Phase 1
Assess preliminary efficacy of OBX-115 regimen by evaluating ORR
Secondary Phase 2
Evaluate safety and tolerability of OBX 115 based on the collected AE data
Secondary both Phase 1 and Phase 2
Evaluate duration of response DOR To evaluate the duration from the time that criteria are met for CR or PR per RECIST v11 as assessed by the investigator until disease progression or death due to cancer
Evaluate disease control rate DCR To evaluate the percentage of participants with a best overall confirmed response of CR or PR at any time plus stable disease SD for at least 4 weeks per RECIST v11 as assessed by the investigator
Evaluate progression-free survival PFS To evaluate the time from the date of OBX-115 infusion until disease progression per RECIST v11 as assessed by the investigator or death due to any cause
Evaluate overall survival OS To evaluate the time from the date of OBX-115 infusion to death due to any cause
Evaluate feasibility of the manufacturing process Evaluated as the proportion of OBX-115 products initiated for manufacturing that pass release criteria for infusion
Assess the safety and tolerability of OBX-115 regimen
Primary Objective Phase 2
Evaluate preliminary efficacy of OBX-115 regimen as measured by the investigator using objective response rate ORR per Response Evaluation Criteria in Solid Tumors RECIST v11
Secondary Phase 1
Assess preliminary efficacy of OBX-115 regimen by evaluating ORR
Secondary Phase 2
Evaluate safety and tolerability of OBX 115 based on the collected AE data
Secondary both Phase 1 and Phase 2
Evaluate duration of response DOR To evaluate the duration from the time that criteria are met for CR or PR per RECIST v11 as assessed by the investigator until disease progression or death due to cancer
Evaluate disease control rate DCR To evaluate the percentage of participants with a best overall confirmed response of CR or PR at any time plus stable disease SD for at least 4 weeks per RECIST v11 as assessed by the investigator
Evaluate progression-free survival PFS To evaluate the time from the date of OBX-115 infusion until disease progression per RECIST v11 as assessed by the investigator or death due to any cause
Evaluate overall survival OS To evaluate the time from the date of OBX-115 infusion to death due to any cause
Evaluate feasibility of the manufacturing process Evaluated as the proportion of OBX-115 products initiated for manufacturing that pass release criteria for infusion
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