NCT05377905

Microneedle Array Plus Doxorubicin in Cutaneous Squamous Cell Cancer (cSCC)

Phase Ib/II Study of Micro-needle Array Containing Doxorubicin in Immune Competent or Immune-suppressed Patients With Cutaneous Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Falo, Louis, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test a new method of experimental treatment for cutaneous squamous cell skin cancer, using small adhesive-like patches (a micro-needle applicator or MNA for short), which have dozens of very small micro-needles loaded with extremely low doses of doxorubicin, a chemotherapy agent. The overall goal of this study is to test the safety and effectiveness of these patches. The investigators have established the highest tolerated dose at 50 micrograms in a previous study for a different type of cancer that affects the skin. The investigators will thoroughly evaluate the skin where the patches are applied.

Detailed description

This study will evaluate a novel approach to the treatment of cutaneous squamous cell cancer (cSCC) of patients diagnosed previously by skin biopsy with cSCC utilizing a dissolvable microneedle array (MNA) delivery device that is used to directly and specifically deliver a drug to the tumor microenvironment for skin cancer therapy. The investigators will utilize MNAs to deliver a well-characterized, potent chemotherapeutic agent (doxorubicin) to kill topically accessible, cutaneous SCC cells. In addition to directly killing cancer cells, doxorubicin is known to induce an immunologic cell death with the potential to simultaneously convert a cutaneous neoplasm into a highly potent patient specific immunogen capable of inducing innate, adaptive, and tumor specific effector and memory immune responses. Importantly, doxorubicin is currently in clinical use with a well-established safety profile. It is anticipated that use of the MNA-Doxorubicin (MNA-D) delivery system will enable direct and specific delivery of chemotherapy to the tumor, thereby avoiding any potential for systemic toxicity. The study will be conducted using two groups: one group will consist of patients with immunocompetent immune systems and the second group will consist of patients who have had an organ transplant and are considered immunoincompetent.efficacy and safety evaluation. The first phase is now completed. Following a screening/baseline phase, the MNA-D patch application and assessment visits will occur from week 0 through week 3, followed by a rest week and at week 5, up to week 8, a final follow up visit will take place. At the final follow up visit, the remaining cSCC lesion will be removed in a standard of care manner to ensure that all tissue margins are clear of the cSCC.

Conditions

• Cutaneous Squamous Cell Carcinoma
• Skin Cancers - Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Microneedle Array Doxorubicin (MNA-D)	The Microneedle array patch is loaded/prepared with a total dose of 50 micrograms of Doxorubicin and is applied to a single selected cSCC remnant for a period of 20 minutes for a total of 4 weekly applications

Timeline

• Start date: 2023-09-13
• Primary completion: 2027-03-31
• Completion: 2027-12-31
• First posted: 2022-05-17
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study