Study of Intralesional FLD-103 in Subjects With Basal Cell Carcinoma (BCC)
ConditionNodular Basal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorFeldan Therapeutics
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
You are between 18 and 85 years old.
You are willing to attend all study visits and follow the study procedures.
You have been diagnosed with at least one nodular basal cell carcinoma (a type of skin cancer) that has never been treated and suitable for treatment and final excision by the Investigator.
You are willing to avoid certain medications during the study as instructed by the study doctor.
Disqualifiers
You are currently breastfeeding.
You have a known allergy or sensitivity to any ingredient in the study drug or to red tattoo ink.
Your skin lesion is located in a high-risk area, such as near the eyes, nose, ears, lips, scalp, or on the hands or fingers.
Your skin lesion needs to be removed urgently.
Trial design
Design model
Sequential
Treatments tested in this trial
Intralesional FLD-103
DrugIntralesional and perilesional injection of FLD-103
Treatment groups
48 Participants
are divided into 11 treatment groups11
Treatment groupsSee each treatment group below.
Group A: SAD Dose 1Experimental treatment 1 intervention
Group B: SAD Dose 2Experimental treatment 1 intervention
Group C: SAD Dose 3Experimental treatment 1 intervention
Group D: SAD Dose 4Experimental treatment 1 intervention
Group E: MAD Dose 1Experimental treatment 1 intervention
Group F: MAD Dose 2Experimental treatment 1 intervention
Group G: MAD Dose 3Experimental treatment 1 intervention
Group H: MAD Dose 4Experimental treatment 1 intervention
Group I: MAD-FV Dose 2Experimental treatment 1 intervention
Group J: MAD-FV Dose 3Experimental treatment 1 intervention
Group K: MAD-FV Dose 4Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Frequency, severity and relationship of Treatment Emergent Adverse events (TEAEs)
Time frame
From enrollment until the end-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)2
Local Skin Response (LSR) and other potential localised responses
Time frame
From enrollment until the end-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)Secondary outcomes
1
Maximum observed concentration (Cmax)
Time frame
From enrollment until the end of treatment (EOT) (up to Day 8 for SAD / up to Day 36 for MAD/MAD-FV)2
Time to Cmax (Tmax)
Time frame
From enrollment until the end of treatment (EOT) (up to Day 8 for SAD / up to Day 36 for MAD/MAD-FV)3
Area under the concentration-time curve from 0 to time of last quantifiable concentration (AUClast)
Time frame
From enrollment until the end of treatment (EOT) (up to Day 8 for SAD / up to Day 36 for MAD/MAD-FV)Other outcomes
1
Rate of histological clearance of the nBCC
Time frame
End-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)2
Overall response rate (ORR)
Time frame
End-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)3
Complete response rate (CRR)
Time frame
End-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov