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RECRUITING
NCT06830863
PHASE1/PHASE2

A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal Toxicity

Sponsor: Azitra Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

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