Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-27 @ 9:51 PM
Study NCT ID:
NCT04911166
Status:
TERMINATED
Last Update Posted:
2025-06-17
First Post:
2021-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Trial of Atezolizumab and Interleukin-12 Gene Therapy in Metastatic Non-Small Cell Lung Cancer With Progression on First-Line Immunotherapy With or Without Chemotherapy
Sponsor:
The Methodist Hospital Research Institute
Organization:
Study Overview
Official Title:
Phase I Trial of Atezolizumab and Interleukin-12 Gene Therapy in Metastatic Non-Small Cell Lung Cancer With Progression on First-Line Immunotherapy With or Without Chemotherapy
Status:
TERMINATED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase I study evaluating the safety of atezolizumab in combination with ADV/IL-12 gene therapy in patients with metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on first-line immunotherapy with or without chemotherapy.
Detailed Description:
This is a Phase I study evaluating the safety of atezolizumab in combination with adenoviral-mediated interleukin-12 (ADV/IL-12) gene therapy in patients with metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on first-line immunotherapy with or without chemotherapy. Approximately 16 patients will be enrolled on the study. The primary endpoint will be the safety of the atezolizumab and ADV/IL-12 gene therapy combination and will be determined using the Bayesian model averaging-continual reassessment method (BMA-CRM). ADV/IL-12 will be intratumorally injected on Day 0 of the study. The starting dose of ADV/IL-12 will be 5 × 1011 vp. ADV/IL-12 dose level will de-escalate based on Dose Limiting Toxicity (DLT) occurrence: dose level -1, 3 × 1011 vp and dose level -2, 1 × 1011 vp. The starting dose, based on the dose range explored in prior studies, is expected to have activity and dosing changes are only in place in the event that toxicity is demonstrated. Starting on Day 2 of the study, atezolizumab will be administered at 1200 mg IV every 3 weeks (Q3W) for 2 cycles. Patients with stable disease or better after completion of 2 cycles of atezolizumab will continue to receive atezolizumab Q3W until disease progression, unacceptable toxicity, or up to 12 months.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: