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

Part of paid clinical trials in Bowling Green, Kentucky.

Sponsor
Feldan Therapeutics
Study ID
NCT07670858
Phase
PHASE1
Status
Recruiting
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Conditions

  • Nodular Basal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Intralesional FLD-103 — DRUG
    Intralesional and perilesional injection of FLD-103

Study Details

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.

Key Dates

Start date
Oct 30, 2024
Status verified
Jun 2026
Primary completion
Feb 28, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SAD Dose 1
    A single dose of FLD-103 0.5 mg/mL (lesion size-determined volume)
  • Experimental: SAD Dose 2
    A single dose of FLD-103 1 mg/mL (lesion size-determined volume)
  • Experimental: SAD Dose 3
    A single dose of FLD-103 3 mg/mL (lesion size-determined volume)
  • Experimental: SAD Dose 4
    A single dose of FLD-103 5 mg/mL (lesion size-determined volume)
  • Experimental: MAD Dose 1
    A multiple doses of FLD-103 0.5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
  • Experimental: MAD Dose 2
    A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
  • Experimental: MAD Dose 3
    A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
  • Experimental: MAD Dose 4
    A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
  • Experimental: MAD-FV Dose 2
    A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
  • Experimental: MAD-FV Dose 3
    A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
  • Experimental: MAD-FV Dose 4
    A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks with a fixed volume (FV).

Primary Outcome Measure

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) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Equity MedicalBowling GreenKentucky42104-
Equity MedicalNew YorkNew York10023-

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