Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
NCT ID:
NCT05081492
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.
Study:
NCT05081492
Study Brief:
Protocol Section:
NCT05081492