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

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

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

Study Overview

• Status: Recruiting
• Conditions: EGFR Inhibitor-associated Rash
• Intervention / Treatment: Drug: ATR04-484; Drug: Vehicle

Detailed Description

This is a multicenter, randomized, blinded, vehicle-controlled Phase 1/2 trial of topically applied ATR04-484 in adult patients with moderate to severe EGFRi-related non-infected dermal toxicity affecting the face. The neck, chest, back, and other areas may also be affected.

The safety, bioavailability, pharmacodynamics (PD), and preliminary effect of ATR04-484 (at a single concentration) will be compared to that of its vehicle, in 2 patient cohorts. In each cohort, eligible patients will be randomized (3:1 ratio) to ATR04-484 or its vehicle. The initial cohort (n = 8) will receive a single 4 g application of the study drug to the face, chest, and back, followed by a 7-day observation period. Upon completion of this observation period, the patients in this cohort may continue in the study with daily applications of study drug for an additional 28 days. Following a safety observation period, a subsequent cohort (n = 24) may be enrolled and will receive a 4 g application of the study drug once daily for 28 days. Each cohort will be followed for 28 days after the last application of study drug.

Clinical assessments of treatment effect will be evaluated at each area that has received a full application of study drug (coverage of all lesional surfaces). The primary endpoint is safety and tolerability. Secondary endpoints including clinical efficacy, including: (1) the severity of the dermal toxicity using a 5-point regional assessment scale, based on modified CTCAE descriptors for skin toxicity (including a score of 0 for clear or unaffected skin through 4 for severely affected skin); (2) numeric rating scales for pruritus and pain; and (3) a quality-of-life assessment (Functional Assessment of Cancer Therapy-EGFRI 18 [FACT-EGFRI 18]). Bioavailability of ATR04-484 will also be assessed.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Mary Spellman, MD; Phone Number: 415-652-7962; Email: spellman@azitrainc.com

Study Locations

• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Recruiting
      • Genesis Cancer and Blood Institute
      • Contact: Laura,; Phone Number: 63839 501-624-7700; Email: Laura.Sellers@aoncology.com
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale University School Of Medicine
      • Contact: Devon, Clinical Research Coordinator; Phone Number: 203-785-2270
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone
      • Contact: Sevinj, Sr. Clinical Research Coordinator; Phone Number: 212-263-5244; Email: Sevinj.Sasunova@nyulangone.org
  • Ohio
    • Gahanna, Ohio, United States, 43230
      • Recruiting
      • The Ohio State University
      • Contact: Elizabeth, Clinical Research Coordinator; Phone Number: 614-293-9306; Email: Elizabeth.Begle@osumc.edu
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson
      • Contact: Angelica, Sr. Coordinator, Clinical Research; Phone Number: 832-846-0794; Email: ARRodriguez3@mdanderson.org
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • INOVA Schar Cancer
      • Contact: Stephanie, Senior Director, Clinical Trials Office; Phone Number: 571-472-4724; Email: Stephanie.vanbebber@inova.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ATR04-484; Topically applied ATR04-484	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; Other Names: ATR-04
Placebo Comparator: Vehicle; Topically applied vehicle	Drug: Vehicle; Topically applied vehicle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability	Treatment-emergent adverse events	57 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of dermal toxicity	Investigator assessment of dermal toxicity using a 5-point regional assessment scale, based on modified CTCAE descriptors for skin toxicity (including a score of 0 for clear or unaffected skin through 4 for severely affected skin).	57 days
Pruritus	Patient reported via numeric rating scale for reflective (24 hour) pruritus	57 days
Quality-of-life assessment	Patient reported using Functional Assessment of Cancer Therapy-EGFRI 18 [FACT-EGFRI 18]	57 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioavailability of ATR04-484	The bioavailability of SE484 will be assessed by qPCR	57 days

Collaborators and Investigators

• Sponsor: Azitra Inc.
• Collaborators: Prosoft Clinical

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): February 15, 2027

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): February 17, 2025

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: EGFR; acneiform; EGFR inhibitor-associated rash; EGFRi
• Other Study ID Numbers: ATR04-EGFR-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No