Intralesional FLD-103 for Skin Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called FLD-103, an experimental drug for basal cell carcinoma, a common type of skin cancer. Researchers aim to determine the safety of FLD-103 and its effectiveness in shrinking tumors. Participants will receive varying doses to identify the optimal dose and assess how the body processes it. Individuals with untreated basal cell carcinoma who are willing to follow study instructions may qualify for this trial. As a Phase 1 trial, this research focuses on understanding how FLD-103 works in people, offering participants the unique opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that FLD-103 is likely to be safe for humans?
Research has shown that injecting FLD-103 directly into skin cancer tumors appears promising. Previous studies found this treatment safe and easy for patients to handle. Treatments like FLD-103 are considered safe and involve only minor procedures. They target the tumor directly, helping to protect the surrounding healthy skin. This method has effectively destroyed tumors without causing pain or major side effects.
The current trial is in its early stages and aims to determine the safety and tolerability of FLD-103. The treatment is still under testing to ensure its safety for people. Participants in past studies generally handled similar treatments well, with few negative effects reported. However, since this trial is still in the early phase, more information is needed to fully understand the safety of FLD-103.12345Why are researchers excited about this trial's treatment?
Unlike the standard treatments for skin cancer, which typically involve surgery, radiation, or topical medications, FLD-103 offers a novel approach by being injected directly into the lesion. Researchers are excited about FLD-103 because it potentially targets the cancer cells more precisely, leading to fewer side effects compared to systemic treatments. This method allows for varying dosages, both single and multiple, tailored to the lesion size or fixed volume, which might enhance its effectiveness and adaptability for different patient needs.
What evidence suggests that FLD-103 might be an effective treatment for Basal Cell Carcinoma?
Research has shown that FLD-103, the investigational treatment in this trial, may help shrink tumors when injected directly into basal cell carcinoma (BCC) spots. Early results suggest that tumor size can decrease by 76% to 89% within one to four months. This outcome is significantly better than untreated cases, where reduction ranges from 58% to 69%. FLD-103 could become an important non-surgical treatment option for people with BCC. Previous studies have shown it to be well tolerated, with most participants not experiencing serious side effects. This trial will administer different dosages of FLD-103 to evaluate its effectiveness and safety.678910
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with basal cell carcinoma (a common type of skin cancer) who are able to visit the clinic regularly. People with other major health issues or certain conditions may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a Single Ascending Dose (SAD) or Multiple Ascending Doses (MAD) of FLD-103 once weekly for four weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- FLD-103
Trial Overview
The study is testing FLD-103, a new drug injected directly into skin cancer tumors. Participants will get either one dose or weekly doses for four weeks, followed by regular checkups to monitor safety and how well the treatment works.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
A single dose of FLD-103 5 mg/mL (lesion size-determined volume)
A single dose of FLD-103 3 mg/mL (lesion size-determined volume)
A single dose of FLD-103 1 mg/mL (lesion size-determined volume)
A single dose of FLD-103 0.5 mg/mL (lesion size-determined volume)
A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
A multiple doses of FLD-103 0.5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Feldan Therapeutics
Lead Sponsor
Citations
FELDAN THERAPEUTICS ANNOUNCES THE ...
FLD-103 is effective in reducing tumour growth following intralesional injection. FLD-103 was well tolerated … daily dosing for up to 28 days.
ANZCTR - Registration
Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of Intralesional FLD-103 in Subjects with Basal Cell Carcinoma (BCC) Non melanoma ...
Skin Cancer Study - Active trials - Evrima Technologies
This study aims to evaluate the safety and effectiveness of FLD-103 for patients with BCC, offering a potential breakthrough in skin cancer treatment.
Advancements in skin cancer treatment: focus on ... - PMC
After one to four months, the decrease was between seventy-six and eighty-nine percent, whereas the untreated group only saw a loss of fifty-eight to sixty-nine ...
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ctv.veeva.com
ctv.veeva.com/study/a-phase-1-study-of-intralesional-fld-103-in-subjects-with-basal-cell-carcinoma-bccA Phase 1 Study of Intralesional FLD-103 in Subjects With ...
The goal of this clinical trial is to determine safety, tolerability, pharmacokinetics, preliminary efficacy, and MTD, of intralesional FLD-103
Results of a phase II, open‐label, non‐comparative study of ...
An open‐label, single‐arm phase II study was performed to assess the efficacy and safety of PV‐10 followed by hypofractionated radiotherapy. Patients had in‐ ...
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australianclinicaltrials.gov.au
australianclinicaltrials.gov.au/anzctr-search-results?search_text=&condition_category=all&purpose_of_study=all&recruitment_status=all&recruitment_sites=all&phase=all&gender=all&healthy_volunteers=allðics_approval=all&condition_code=all&page=169ANZCTR search results | Australian Clinical ...
... Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of Intralesional FLD-103 in Subjects with Basal Cell Carcinoma (BCC). This study aims to ...
Improving the Efficacy of EGFR Inhibitors by Topical ...
In the present study, we found that topical application of an ointment containing miR-634 inhibited in vivo tumor growth without toxicity in a cSCC xenograft ...
TITLE: A Phase I,II,III,or IV Study of Investigational Agent or Device in ...
(3) Data and Safety Monitoring Committee (DSMC): The NYU Cancer Institute DSMC reviews all data for patient safety according to the DSMC policies. This ...
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nccndd.qitian-med.tech
nccndd.qitian-med.tech/nccn-his/%E7%9A%AE%E8%82%A4%E9%B3%9E%E7%8A%B6%E7%BB%86%E8%83%9E%E7%99%8C/%E7%9A%AE%E8%82%A4%E9%B3%9E%E7%8A%B6%E7%BB%86%E8%83%9E%E7%99%8C2022.1%E7%89%88.pdfSquamous Cell Skin Cancer
safety data to support the routine use of electronic surface brachytherapy, and radioisotope brachytherapy should only be considered in ...
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