MedTrace Logo

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

NCT07670858 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-06-29

No results posted yet for this study

Summary

The goal of this clinical trial is to determine safety, tolerability, pharmacokinetics, preliminary efficacy, and Maximum Tolerable Dose (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 Ascending Dose (SAD) of FLD-103 or Multiple Ascending 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.

Conditions

  • Nodular Basal Cell Carcinoma

Interventions

DRUG

Intralesional FLD-103

Intralesional and perilesional injection of FLD-103

Sponsors & Collaborators

  • Feldan Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-30
Primary Completion
2027-02-28
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07670858 on ClinicalTrials.gov