A Phase 1/2 Study to Evaluate the Safety, Bioavailability, and Effect of Topically Administered ATR04-484 for Moderate to Severe EGFRi-Associated Dermal Toxicity (ATR04-EGFR-101)

This research study is to evaluate the safety and efficacy of the investigational study drug, ATR04-484, as a possible treatment for dermal toxicity associated with EGFRi treatment. If you have a moderate to severe skin reaction that your doctor recognizes is due to the EGFRi medication you receive for cancer, you may be able to participate in this study.

ATR04-484 contains a specific strain of a Staphylococcus epidermidis (S. epidermidis) microbe,  which was genetically modified to survive only in the presence of D-alanine (an amino acid that is not present in humans at a meaningful level). 

The purposes of this study are to:

• test the safety and effectiveness of the study drug, ATR04-484, compared to vehicle control  (also referred to as a placebo control, with no active study drug present)
• assess how ATR04-484 affects biomarkers (signals in the blood or skin tissue that may be related to your response to the study drug) and the bacteria on the skin surface compared to vehicle control

For more information, please visit:  https://clinicaltrials.gov/study/NCT06830863

Inova Schar Cancer
A Division of Inova Fairfax Hospital
8081 Innovation Park Drive
Fairfax, VA 22031

• Male or female patients, age ≥18 years at the time of signing the informed consent form
• Currently treated with a Food and Drug Administration (FDA)-approved EGFRi for the treatment of cancer, with or without concurrent chemotherapy, and expected to continue treatment with the EGFRi through the study treatment period
• Grade 2 or 3 non-infected moderate to severe EGFRi-related dermal toxicity affecting the face; the neck, chest, back and other areas may also be affected (will be assessed for severity, no threshold required for entry)
• Must be able to use topical medications reliably and complete questionnaires
• Must have the ability to understand and the willingness to sign a written informed consent prior to enrolling in the study
• Additional inclusion criteria in protocol.

• Pregnancy/breastfeeding
• Significant skin disease other than EGFRi-related dermal toxicity, including atopic dermatitis, psoriasis, vesiculo-bullous lesions, or open wounds (exception may be made for skin disease on the abdomen, groin, buttocks, or extremities; to be discussed with the study Medical Monitor prior to enrollment)
• History of acne vulgaris requiring systemic antibiotic therapy or systemic retinoids within 6 months prior to the diagnosis of EGFRi-related dermal toxicity; or treatment with a systemic retinoid within 3 months prior to Day 1
• Radiation therapy in planned application sites within prior 3 months, or planned during the study period
• Current treatment for cancer other than the prescribed EGFRi that in the opinion of the Investigator, would place the patient at undue risk if the patient were to participate in the study
• Clinically relevant serious co-morbid medical conditions including, but not limited to, active infection requiring antibiotic therapy, unstable angina pectoris, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease
• Active central nervous system disease uncontrolled by standard of care
• Known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B or C
• COVID-19 infection within 4 weeks prior to Day 1
• Known hypersensitivity to any of the ingredients of the study drug (ATR04-484 or vehicle)
• Additional ineligibility in protocol.