Westcourt

Researchers are evaluating the safety, tolerability, drug behavior, and early effects of intralesional FLD-103 in adults with nodular basal cell carcinoma BCC, a type of skin cancer. This Phase 1 trial aims to find a safe dose for future studies and to see if FLD-103 can reduce tumor size. The main questions are about FLD-103s safety, how it moves through and clears from the body, and whether it shrinks tumors. Participants will receive either a single ascending dose SAD or multiple ascending doses MAD of FLD-103 injected into the lesion. Single doses range from 0.5 to 5 mgmL with volumes based on lesion size. Multiple doses are given once weekly for four weeks, with some groups receiving fixed volumes. The study has several dose levels to determine the maximum tolerable dose. During the trial, participants will visit the clinic the day after dosing and weekly for up to four weeks for checkups and tests. Researchers will monitor adverse events and local skin reactions from enrollment until study end up to 36 days for single dose groups and 57 days for multiple dose groups. Blood levels of FLD-103 will be measured to understand how much enters the bloodstream and how long it stays. The total participation lasts up to about two months depending on the dosing group.