Spots Global Cancer Trial Database for DNX-2440 for Resectable Colorectal Liver Metastasis
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Trial Identification
Brief Title: DNX-2440 for Resectable Colorectal Liver Metastasis
Official Title: A Phase I Safety and Window-of-opportunity Study of Preoperative Intratumoral Injection of OX40-ligand Expressing Oncolytic Adenovirus (DNX-2440) in Patients With Resectable Liver Metastasis
Study ID: NCT04714983
Interventions
Study Description
Brief Summary: The purpose of this study is to test an experimental oncolytic adenovirus called DNX-2440 in patients with resectable multifocal (≥ 2 lesions) liver metastasis, who are scheduled to have curative-intent liver resection surgery. Up to 18 patients will receive two sequential intra-tumoral injections of DNX-2440 into a metastatic liver tumor prior to surgery for liver resection, to evaluate safety and biological endpoints across 3 dose levels (dose escalation). Upon conclusion of the dose-escalation phase, the selected safe and biologically appropriate dose will be administered using the same schema for an additional 12 patients with colorectal cancer liver metastasis (expansion cohort) using established biologic endpoints.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
H. Lee Moffitt Cancer Center and Research Institute, Inc., Tampa, Florida, United States
Contact Details
Name: Joan Robbins, Ph.d
Affiliation: DNAtrix, Inc.
Role: STUDY_DIRECTOR
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