Spots Global Cancer Trial Database for START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer
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Trial Identification
Brief Title: START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer
Official Title: A Study to Evaluate the Safety and Immune Activity of PeptiCRAd-1 in Combination With Pembrolizumab in Patients With Injectable Solid Tumors in Indications Known to Express NY-ESO-1 and MAGE-A3
Study ID: NCT05492682
Study Description
Brief Summary: This study is being conducted to explore the immunological mechanism of action of Peptide-coated Conditionally Replicating Adenovirus-1 (PeptiCRAd-1) plus Checkpoint inhibitor (CPI) therapy in multiple cancer types, as well as to obtain early information on the safety of this combination therapy.
Detailed Description: This is a Phase I, open-label, non-randomized, first-in-human study. All patients will be pre-treated with a low dose of intravenous (i.v.) Cyclophosphamide (CPO) followed by monotherapy doses of PeptiCRAd-1. Patients will receive a total of 6 doses of PeptiCRAd-1 during the study. PeptiCRAd-1 will be administered by intratumoral (i.t.) injection with priming doses administered on Days 1, 4, and 8, and the first booster dose on Day 15, followed by combination therapy with PeptiCRAd-1 and i.v. CPI (pembrolizumab).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Krankenhaus Nordwest, Frankfurt, , Germany
National Center for Tumor Diseases, Heidelberg, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Contact Details
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