NCT06782399

Drug Screening of Cutaneous Lesions of Squamous Cell Carcinoma

A Pilot of a Microdevice for in Situ Candidate Drug Screening of Cutaneous Lesions of Squamous Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Oliver Jonas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying the effect of different drugs as possible treatments for squamous cell carcinoma (SCC).

Detailed description

The pilot study will determine the feasibility of using an in situ microdevice to measure local intratumoral response to several cancer treatments in patients with cutaneous lesions of squamous cell carcinoma. This research study is a Pilot Study, which is the first-time investigators are examining this study device in SCC. The treatment received will be the normal standard-of-care treatment for SCC However, the placement and removal of the microdevice is being tested for the first time in this type of cancer. This research study involves drugs that are released by a small implantable microdevice (IMD) as small as the tip of a needle, that is inserted into the tumor and is then removed 3-5 days later. The microdevice can hold up to 20 drugs in very small concentrations that are able to access the cancer through small pores in the device. When the device is removed along with the cancer 3-5 days later, it will be evaluated to understand which drug(s) may be effective to treat these cancers. The U.S. Food and Drug Administration (FDA) has not approved the microdevice a treatment for any disease. AACRF, a research foundation, is supporting this research study by providing funding for the research study, the study drugs and study procedures

Conditions

• Squamous Cell Carcinoma of the Skin
• Squamous Cell Carcinoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Microdevice	Device: Microdevices The microdevice is an investigational miniaturized implantable nanodose drug delivery device. It was developed as a tool with the ultimate goal to help screen several existing and investigational drugs directly within a patient's tumor to identify what drugs are the most effective for treating a patient's cancer. The microdevice releases nanodoses of several approved drugs into the tumor, and is then excised minimally invasively several days later. Other: Standard of care therapy Participant to receive standard of care therapy as previously determined by participant's treating oncologist and/or dermatologist, which may include a skin-directed or systemic therapy

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2025-01-17
• Last updated: 2025-01-17

Regulatory

• FDA-regulated drug study