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

ConditionEGFR Inhibitor-associated Rash

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorAzitra Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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
Vehicle
Drug
Topically applied vehicle.

Treatment groups

32 Participants

are divided into 2 treatment groups

Group A: ATR04-484Experimental treatment 1 intervention

Group B: VehiclePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Safety and tolerability

Treatment-emergent adverse events

Time frame

57 days

Secondary outcomes

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).

Time frame

57 days

Pruritus

Patient reported via numeric rating scale for reflective (24 hour) pruritus

Time frame

57 days

Quality-of-life assessment

Patient reported using Functional Assessment of Cancer Therapy-EGFRI 18 \[FACT-EGFRI 18\]

Time frame

57 days

Other outcomes

Bioavailability of ATR04-484

The bioavailability of SE484 will be assessed by qPCR

Time frame

57 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azitra Inc.

Lead sponsor

Prosoft Clinical

Collaborator

Source ClinicalTrials.gov

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