Recruiting
Phase 1
Phase 2

ATR04-484

Sponsor:

Azitra Inc.

Code:

NCT06830863

Conditions

EGFR Inhibitor-associated Rash

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ATR04-484

Vehicle

Study Details

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

Study ID

NCT06830863

Start date

Aug 25, 2025

Status verified date

Oct, 2026

Completion date

Sep 15, 2027

Anticipated

Primary completion date

Jul 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ATR04-484

Topically applied ATR04-484

placebo comparator: Vehicle

Topically applied vehicle

Interventions

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.

Primary outcome measure

  • Safety and tolerability [ Time Frame: 57 days ]

Central Contacts and Locations

Central contacts

Mary Spellman, MD

415-652-7962spellman@azitrainc.com

Locations

Genesis Cancer and Blood Institute

Recruiting

Hot Springs, Arkansas, United States, 71913

Contacts

Laura,

501-624-7700Laura.Sellers@aoncology.com

Yale University School of Medicine

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Rehema, Clinical Research Coordinator

203-785-2270

NYU Langone

Recruiting

New York, New York, United States, 10016

Contacts

Sevinj, Sr. Clinical Research Coordinator

212-263-5244Sevinj.Sasunova@nyulangone.org

The Ohio State University

Recruiting

Gahanna, Ohio, United States, 43230

Contacts

Elizabeth, Clinical Research Coordinator

614-293-9306Elizabeth.Begle@osumc.edu

MD Anderson

Recruiting

Houston, Texas, United States, 77030

Contacts

Angelica, Sr. Coordinator, Clinical Research

832-846-0794ARRodriguez3@mdanderson.org

Inova Schar Cancer

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Stephanie, Senior Director, Clinical Trials Office

571-472-4724Stephanie.vanbebber@inova.org

More Information

Sponsor

Azitra Inc.

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • EGFR
  • acneiform
  • EGFR inhibitor-associated rash
  • EGFRi

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Azitra Inc. on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.