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

NCT06830863 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ATR04-EGFR-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 6

Brief 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

Conditions

EGFR Inhibitor-associated Rash

Keywords

EGFR; acneiform; EGFR inhibitor-associated rash; EGFRi

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Treatment-emergent adverse events

  57 days

Secondary Outcomes (3)

• Severity of dermal toxicity

  57 days

• Pruritus

  57 days

• Quality-of-life assessment

  57 days

Other Outcomes (1)

• Bioavailability of ATR04-484

  57 days

Study Arms (2)

ATR04-484

EXPERIMENTAL

Topically applied ATR04-484

Drug: ATR04-484

Vehicle

PLACEBO COMPARATOR

Topically applied vehicle

Drug: Vehicle

Interventions

ATR04-484 DRUG

ATR04-484 is a recombinant live biotherapeutic product (rLBP) containing the engineered S. epidermidis strain SE484 in an ointment formulation for topical use

Also known as: ATR-04

ATR04-484

Vehicle DRUG

Topically applied vehicle.

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Azitra Inc.: lead
• Prosoft Clinical: collaborator

Study Sites (6)

Genesis Cancer and Blood Institute

Hot Springs, Arkansas, 71913, United States

RECRUITING

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

RECRUITING

NYU Langone

New York, New York, 10016, United States

RECRUITING

The Ohio State University

Gahanna, Ohio, 43230, United States

RECRUITING

MD Anderson

Houston, Texas, 77030, United States

RECRUITING

Inova Schar Cancer

Fairfax, Virginia, 22031, United States

RECRUITING

Central Study Contacts

Mary Spellman, MD

CONTACT

415-652-7962; spellman@azitrainc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 17, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)