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RECRUITING
NCT07670858
PHASE1

A Phase 1 Study of Intralesional FLD-103 in Subjects With Basal Cell Carcinoma (BCC)

Sponsor: Feldan Therapeutics

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to determine safety, tolerability, pharmacokinetics, preliminary efficacy, and MTD, of intralesional FLD-103 when administered to subjects with Basal Cell Carcinoma (BCC). The main questions it aims to answer are: * Is FLD-103 safe and well tolerated? * What is a safe dose of FLD-103 for future studies? * How much FLD-103 enters the bloodstream and how long does it take to be cleared from the body? * Does FLD-103 reduce the size of the tumor? Participants will: * Receive either a single dose (SAD) of FLD-103 or multiple doses (MAD) of FLD-103 once weekly for four (4) weeks. * Visit the clinic a day after receiving a dose and once weekly for four (4) weeks after that for checkups and tests.

Official title: A Phase 1, First-In-Human, Single and Multiple Ascending Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Clinical Efficacy of Intralesional FLD-103 in Subjects With Basal Cell Carcinoma (BCC).

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2024-10-30

Completion Date

2027-03

Last Updated

2026-06-26

Healthy Volunteers

No

Interventions

DRUG

Intralesional FLD-103

Intralesional and perilesional injection of FLD-103

Locations (9)

Equity Medical

Bowling Green, Kentucky, United States

Equity Medical

New York, New York, United States

Woden Dermatology

Phillip, Australian Capital Territory, Australia

Novatrials

Charlestown, New South Wales, Australia

Scientia Clinical Research

Randwick, New South Wales, Australia

Innovate Clinical Research

Waitara, New South Wales, Australia

FNQH Cairns Skin Cancer Clinic

Westcourt, Queensland, Australia

Translational Research Institute

Woolloongabba, Queensland, Australia

Veracity Clinical Research

Woolloongabba, Queensland, Australia