Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-27 @ 5:21 AM
Study NCT ID:
NCT05081492
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-06
First Post:
2021-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CF33-hNIS-antiPDL1 for the Treatment of Metastatic Triple Negative Breast Cancer
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
A Phase I, First-in-Human Study of Intratumoral Administration of CF33-hNIS-antiPDL1, A Novel Chimeric Oncolytic Poxvirus Encoding Human Sodium Iodide Symporter (HNIS) in Patients With Metastatic Triple Negative Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
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:
None
Brief Summary:
This phase I trial tests the safety, side effects, and best dose of CF33-hNIS-antiPDL1 in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic). CF33-hNIS-antiPDL1 is an oncolytic virus. This is a virus that is designed to infect tumor cells and break them down.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine the safety and tolerability of a novel chimeric oncolytic orthopoxvirus, oncolytic virus CF33-expressing hNIS/Anti-PD-L1 antibody (CF33-hNIS-antiPDL1), by the evaluation of toxicities including: type, frequency, severity, attribution, time course, reversibility and duration according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 criteria.
SECONDARY OBJECTIVES:
I. To determine the optimal biologic dose (OBD) (defined as a safe dose that induces an immune response in tumors \[increase checkpoint target PD-L1 by at least 5% and/or increase T cell infiltration by at least 10%\]) and the recommended phase II dose (RP2D) for future expansion trial.
II. To determine tumor response rates by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 (primary) and immune-modified (i)RECIST (secondary).
III. To document possible therapeutic efficacy and evaluate progression-free survival, overall survival and response.
EXPLORATORY OBJECTIVE:
I. To determine the immune and genomic profiles of tumors before and after CF33-hNIS-antiPDL1 therapy.
OUTLINE: This is a dose-escalation study.
Patients receive CF33-hNIS-antiPDL1 intratumorally (IT) on days 1 and 15. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, then every 3 months for 1 year.
I. To determine the safety and tolerability of a novel chimeric oncolytic orthopoxvirus, oncolytic virus CF33-expressing hNIS/Anti-PD-L1 antibody (CF33-hNIS-antiPDL1), by the evaluation of toxicities including: type, frequency, severity, attribution, time course, reversibility and duration according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 criteria.
SECONDARY OBJECTIVES:
I. To determine the optimal biologic dose (OBD) (defined as a safe dose that induces an immune response in tumors \[increase checkpoint target PD-L1 by at least 5% and/or increase T cell infiltration by at least 10%\]) and the recommended phase II dose (RP2D) for future expansion trial.
II. To determine tumor response rates by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 (primary) and immune-modified (i)RECIST (secondary).
III. To document possible therapeutic efficacy and evaluate progression-free survival, overall survival and response.
EXPLORATORY OBJECTIVE:
I. To determine the immune and genomic profiles of tumors before and after CF33-hNIS-antiPDL1 therapy.
OUTLINE: This is a dose-escalation study.
Patients receive CF33-hNIS-antiPDL1 intratumorally (IT) on days 1 and 15. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, then every 3 months for 1 year.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-08983 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 21094 | OTHER | City of Hope Medical Center | View | |
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |