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| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12624001138572 | Other Identifier | ANZCTR |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD Dose 1 | Experimental | A single dose of FLD-103 0.5 mg/mL (lesion size-determined volume) |
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| SAD Dose 2 | Experimental | A single dose of FLD-103 1 mg/mL (lesion size-determined volume) |
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| SAD Dose 3 | Experimental | A single dose of FLD-103 3 mg/mL (lesion size-determined volume) |
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| SAD Dose 4 | Experimental | A single dose of FLD-103 5 mg/mL (lesion size-determined volume) |
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| MAD Dose 1 | Experimental | A multiple doses of FLD-103 0.5 mg/mL once weekly for four (4) weeks (lesion size-determined volume). |
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| MAD Dose 2 | Experimental | A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks (lesion size-determined volume). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intralesional FLD-103 | Drug | Intralesional and perilesional injection of FLD-103 |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency, severity and relationship of Treatment Emergent Adverse events (TEAEs) | From enrollment until the end-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV) | |
| Local Skin Response (LSR) and other potential localised responses | From enrollment until the end-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | From enrollment until the end of treatment (EOT) (up to Day 8 for SAD / up to Day 36 for MAD/MAD-FV) | |
| Time to Cmax (Tmax) | From enrollment until the end of treatment (EOT) (up to Day 8 for SAD / up to Day 36 for MAD/MAD-FV) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of histological clearance of the nBCC | End-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV) | |
| Overall response rate (ORR) | End-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine Lippé | Contact | 1 581-397-8597 | clippe@feldan.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Equity Medical | Recruiting | Bowling Green | Kentucky | 42104 | United States | |
| Equity Medical |
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This study will use a traditional 3 + 3 design for both SAD and MAD Cohorts with lesion size-determined volume of FLD-103. After review of both SAD and MAD at Dose Level 2, at the discretion of the sponsor, cohorts with fixed 2 mL volume dosing may be investigated. MAD-fixed volume Cohorts may enrol three (3) or six (6) subjects, based on emerging safety and preliminary efficacy data, in sequence (not following the 3 + 3 design).
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| MAD Dose 3 | Experimental | A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks (lesion size-determined volume). |
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| MAD Dose 4 | Experimental | A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks (lesion size-determined volume). |
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| MAD-FV Dose 2 | Experimental | A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks with a fixed volume (FV). |
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| MAD-FV Dose 3 | Experimental | A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks with a fixed volume (FV). |
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| MAD-FV Dose 4 | Experimental | A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks with a fixed volume (FV). |
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| Area under the concentration-time curve from 0 to time of last quantifiable concentration (AUClast) | From enrollment until the end of treatment (EOT) (up to Day 8 for SAD / up to Day 36 for MAD/MAD-FV) |
| Complete response rate (CRR) | End-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV) |
| Not yet recruiting |
| New York |
| New York |
| 10023 |
| United States |
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