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Clinical Trial Summary

This is a 3-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, tolerability, MTD, and objective antitumor efficacy of ascending dose strengths of LTX 315 when administered intratumorally to adults with biopsy proven basal cell carcinoma (BCC). The study is expected to enroll approximately 66 subjects with a histological diagnosis of BCC in at least 1 eligible target lesion (confirmed by punch biopsy).


Clinical Trial Description

This is a 3-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, tolerability, maximum tolerated dose (MTD), and objective antitumor efficacy of ascending dose strengths of LTX 315 when administered intratumorally to adults with biopsy proven BCC. The study is expected to enroll approximately 66 subjects with a histological diagnosis of BCC in at least 1 eligible target lesion (confirmed by punch biopsy). All enrolled subjects will receive LTX-315 intradermal injection on an outpatient basis into up to 2 target lesions. In all Parts of the study (1, 2, or 3, as below), each 7 day treatment week comprises up to 3 consecutive treatment days followed by a no-treatment period of at least 4 days. Dosing will commence in a single target lesion. Once a lesion has necrosed, treatment of that lesion stops, and treatment of subsequent target lesions (up to 2 total) may continue on Day 1 of the following week. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05188729
Study type Interventional
Source Verrica Pharmaceuticals Inc.
Contact Project Manager
Phone 813-708-7240
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date January 15, 2022
Completion date February 28, 2023

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