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
Azitra Inc.
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
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugATR04-484
ATR04-484 is a recombinant live biotherapeutic product (rLBP) containing the engineered S. epidermidis strain SE484 in an ointment formulation for topical use
- DrugVehicle
Topically applied vehicle.
Locations (6)
- Genesis Cancer and Blood InstituteHot Springs, Arkansas
- Yale University School of MedicineNew Haven, Connecticut
- NYU LangoneNew York, New York
- The Ohio State UniversityGahanna, Ohio
- MD AndersonHouston, Texas
- Inova Schar CancerFairfax, Virginia