Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598371
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
A Phase 12 Study of KSQ-004EX Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate Genes Encoding SOCS1 and Regnase-1 in Patients With Select Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 12 Study of KSQ-004EX Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate Genes Encoding SOCS1 and Regnase-1 in Patients With Select Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase 1 is to find the recommended dose of KSQ-004EX to give to participants with advanced solid tumors
Phase 2 is to learn if KSQ-004EX at the recommended dose found in Phase1 can help to control advanced solid tumors
The safety and effects of KSQ-004EX will also be studied in both phases
Phase 2 is to learn if KSQ-004EX at the recommended dose found in Phase1 can help to control advanced solid tumors
The safety and effects of KSQ-004EX will also be studied in both phases
Detailed Description:
Phase 1 Dose Escalation
Primary Objective
To evaluate the safety and tolerability of KSQ-004EX in adult participants with advanced solid tumors melanoma NSCLC HNSCC CRC pancreatic cancer and cervical cancer Secondary Objectives
Determine expansion dose
Assess the safety and tolerability of KSQ-004EX in participants with advanced solid tumors melanoma NSCLC HNSCC CRC pancreatic cancer and cervical cancer
Evaluate preliminary anti-tumor activity of KSQ-004EX in participants with advanced solid tumors
Evaluate the feasibility of the manufacturing process
Phase 2 Expansion Primary Objective
To assess the anti-tumor activity of KSQ-004EX in participants with advanced malignant solid tumors Secondary Objectives
Assess the safety and tolerability of KSQ-004EX in participants with advanced solid tumors melanoma NSCLC HNSCC CRC pancreatic cancer and cervical cancer
Evaluate anti-tumor activity of KSQ-004EX in participants with advanced malignant solid tumors
Evaluate overall survival OS
Evaluate the feasibility of the manufacturing process
Primary Objective
To evaluate the safety and tolerability of KSQ-004EX in adult participants with advanced solid tumors melanoma NSCLC HNSCC CRC pancreatic cancer and cervical cancer Secondary Objectives
Determine expansion dose
Assess the safety and tolerability of KSQ-004EX in participants with advanced solid tumors melanoma NSCLC HNSCC CRC pancreatic cancer and cervical cancer
Evaluate preliminary anti-tumor activity of KSQ-004EX in participants with advanced solid tumors
Evaluate the feasibility of the manufacturing process
Phase 2 Expansion Primary Objective
To assess the anti-tumor activity of KSQ-004EX in participants with advanced malignant solid tumors Secondary Objectives
Assess the safety and tolerability of KSQ-004EX in participants with advanced solid tumors melanoma NSCLC HNSCC CRC pancreatic cancer and cervical cancer
Evaluate anti-tumor activity of KSQ-004EX in participants with advanced malignant solid tumors
Evaluate overall survival OS
Evaluate the feasibility of the manufacturing process
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