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Recruiting Phase 1/2

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
2026-10-13

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
No
Inclusion Criteria: * Adults ≥18 years of age * Currently treated with an FDA-approved EGFRi, KRASi, or MEKi (or other medications in the pathway, if approved by the Medical Monitor) for the treatment of cancer with or without concurrent chemotherapy, or for neurofibromatosis, and expected to continue treatment with the medication through the study treatment period * Has Grade 2 or 3 non-infected moderate to severe dermal toxicity affecting the face (the neck, chest, back and other areas may also be affected); Grade 1 toxicity may be permitted in up to 25% of enrolled patients 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 7 days prior to baseline; treatment with systemic antibiotics or systemic corticosteroids within 7 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)

FacilityCityRegionStatus
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