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

NCT06830863 · tracked via the Priya Life Science USA tracker

Sponsor

Azitra Inc.

Phase

Phase 1/2

Started

2025-08-25

Last updated

2026-02-11

Condition(s) studied

EGFR Inhibitor-associated Rash

Investigational drug(s) / intervention(s)

ATR04-484Vehicle

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.

Study 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Adults ≥18 years of age * Has 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) Exclusion Criteria: * Significant skin disease other than EGFRi-related dermal toxicity * Treatment with topical mid- to high-potency topical corticosteroids, or topical antibiotics or antibacterial washes on the face, neck, chest, or back within 14 days prior to baseline; treatment with systemic antibiotics or systemic corticosteroids within 14 days prior to baseline * Residing with an immunocompromised person residing with them in the same dwelling from the baseline visit through 2 weeks after the treatment period

Primary outcome measure(s)

Safety and tolerability — 57 days
Treatment-emergent adverse events

Trial sites (6)

Facility	City	Region	Status
Genesis Cancer and Blood Institute	Hot Springs	Arkansas	Recruiting
Yale University School of Medicine	New Haven	Connecticut	Recruiting
NYU Langone	New York	New York	Recruiting
The Ohio State University	Gahanna	Ohio	Recruiting
MD Anderson	Houston	Texas	Recruiting
Inova Schar Cancer	Fairfax	Virginia	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06830863 on ClinicalTrials.gov ↗ ← All trials in the USA