What this study is
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
What's being tested
- ATR04-484
Intervention · DRUG
ATR04-484 is a recombinant live biotherapeutic product (rLBP) containing the engineered S. epidermidis strain SE484 in an ointment formulation for topical use
- Vehicle
Intervention · DRUG
Topically applied vehicle.
Study details
- Official title
- 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
- Sponsor
- Azitra Inc.
- Conditions
- EGFR Inhibitor-associated Rash
- Enrolling
- 32 people
- Starts
- 2025-08-25
- Est. completion
- 2027-09-15
- Design
- Quadruple-blind, randomized, parallel groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join 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 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (6)
6 openGenesis Cancer and Blood Institute
Hot Springs, Arkansas, United States
- Laura, · Contact501-624-7700 ext. 63839Laura.Sellers@aoncology.com
RecruitingYale University School of Medicine
New Haven, Connecticut, United States
- Rehema, Clinical Research Coordinator · Contact203-785-2270
RecruitingNYU Langone
New York, New York, United States
- Sevinj, Sr. Clinical Research Coordinator · Contact212-263-5244Sevinj.Sasunova@nyulangone.org
RecruitingThe Ohio State University
Gahanna, Ohio, United States
- Elizabeth, Clinical Research Coordinator · Contact614-293-9306Elizabeth.Begle@osumc.edu
RecruitingMD Anderson
Houston, Texas, United States
- Angelica, Sr. Coordinator, Clinical Research · Contact832-846-0794ARRodriguez3@mdanderson.org
RecruitingInova Schar Cancer
Fairfax, Virginia, United States
- Stephanie, Senior Director, Clinical Trials Office · Contact571-472-4724Stephanie.vanbebber@inova.org
Recruiting
Study team
Sponsor
Azitra Inc.
Study ID ATR04-EGFR-101
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.