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A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal Toxicity
Sponsor: Azitra Inc.
Summary
The goal of this randomized clinical trial is to learn if topical treatment with ATR04-484 can treat skin rash in patients undergoing EGFR inhibitor (EGFRi) therapy. The primary goal of the study is to determine safety and tolerability of ATR04-484, and the secondary goal of the study is to assess efficacy signals of ATR04-484. Researchers will compare treatment of ATR04-484 to its vehicle. Participants will: * Apply ATR04-484 or vehicle daily for 28 days * Visit the clinic periodically for evaluation and sample collection
Official title: A Phase 1/2, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety, Bioavailability, and Effect of Topically Administered ATR04-484 for Moderate to Severe EGFRi-Associated Dermal Toxicity
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2025-08-25
Completion Date
2027-02-15
Last Updated
2026-02-11
Healthy Volunteers
No
Conditions
Interventions
ATR04-484
ATR04-484 is a recombinant live biotherapeutic product (rLBP) containing the engineered S. epidermidis strain SE484 in an ointment formulation for topical use
Vehicle
Topically applied vehicle.
Locations (6)
Genesis Cancer and Blood Institute
Hot Springs, Arkansas, United States
Yale University School of Medicine
New Haven, Connecticut, United States
NYU Langone
New York, New York, United States
The Ohio State University
Gahanna, Ohio, United States
MD Anderson
Houston, Texas, United States
Inova Schar Cancer
Fairfax, Virginia, United States