EGFR Inhibitor-associated RashPhase 1/2NCT06830863
A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal Toxicity
A Phase 1/2 study testing ATR04-484 in people with EGFR Inhibitor-associated Rash, run by Azitra Inc. at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR Inhibitor-associated Rash
- What is being tested?
- ATR04-484
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 6 sitesUnited States
- Study dates
- 25 Aug 2025to 15 Sep 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Inova Schar Cancer
Fairfax, Virginia, 22031
Stephanie, Senior Director, Clinical Trials Office, 571-472-4724, Stephanie.vanbebber@inova.org
- Recruiting
The Ohio State University
Gahanna, Ohio, 43230
Elizabeth, Clinical Research Coordinator, 614-293-9306, Elizabeth.Begle@osumc.edu
- Recruiting
Genesis Cancer and Blood Institute
Hot Springs, Arkansas, 71913
Laura,, 501-624-7700 ext. 63839, Laura.Sellers@aoncology.com
- Recruiting
MD Anderson
Houston, Texas, 77030
Angelica, Sr. Coordinator, Clinical Research, 832-846-0794, ARRodriguez3@mdanderson.org
- Recruiting
Yale University School of Medicine
New Haven, Connecticut, 06510
Rehema, Clinical Research Coordinator, 203-785-2270
- Recruiting
NYU Langone
New York, New York, 10016
Sevinj, Sr. Clinical Research Coordinator, 212-263-5244, Sevinj.Sasunova@nyulangone.org
About this study
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
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
Read the 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.
- Conditions
- EGFR Inhibitor-associated Rash
- Being tested
- ATR04-484, Vehicle
- Keywords
- EGFR, acneiform, EGFR inhibitor-associated rash, EGFRi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATR04-484Drug
Also called ATR-04
ATR04-484 is a recombinant live biotherapeutic product (rLBP) containing the engineered S. epidermidis strain SE484 in an ointment formulation for topical use
VehicleDrug
Topically applied vehicle.
| Study group | Role | What they receive |
|---|---|---|
| ATR04-484 | Experimental | Topically applied ATR04-484 Receives: Drug: ATR04-484 |
| Vehicle | Placebo comparator | Topically applied vehicle Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Treatment-emergent adverse events
Measured: 57 days
Secondary outcomes (3)
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).
Measured: 57 days
Pruritus
Patient reported via numeric rating scale for reflective (24 hour) pruritus
Measured: 57 days
Quality-of-life assessment
Patient reported using Functional Assessment of Cancer Therapy-EGFRI 18 [FACT-EGFRI 18]
Measured: 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start25 Aug 2025
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Inhibitor-associated RashStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azitra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Prosoft Clinical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830863
- Sponsor's protocol ID
- ATR04-EGFR-101
- Status last verified
- Oct 2026
- First submitted
- 12 Feb 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06830863
- Acronym / sponsor ID
- ATR04-EGFR-101
- Conditions
- EGFR Inhibitor-associated Rash
- Keywords
- EGFR, acneiform, EGFR inhibitor-associated rash, EGFRi
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Azitra Inc.Industry (pharma, biotech, devices)
- Collaborators
- Prosoft Clinical
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATR04-484 | Experimental | Drug: ATR04-484Topically applied ATR04-484 |
| Vehicle | Placebo comparator | Drug: VehicleTopically applied vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATR04-484Also: ATR-04ATR04-484 is a recombinant live biotherapeutic product (rLBP) containing the engineered S. epidermidis strain SE484 in an ointment formulation for topical use | Drug | ATR04-484 |
| VehicleTopically applied vehicle. | Drug | Vehicle |
Primary outcome
Safety and tolerability
Time frame: 57 days
Treatment-emergent adverse events
3 secondary outcomes
Severity of dermal toxicity
Time frame: 57 days
Pruritus
Time frame: 57 days
Quality-of-life assessment
Time frame: 57 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for EGFR Inhibitor-associated Rash
RecruitingPhase 2
Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors
Acneiform Eruption Due to Chemical, Xerosis Cutis
RecruitingPhase 2
TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis
EGFR Inhibitor-associated Rash
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ATR04-484 in people with EGFR Inhibitor-associated Rash, run by Azitra Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Spellman, MD (415-652-7962, spellman@azitrainc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: 57 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.