Study to Evaluate the Safety of ATR-04

• Status: Suspended
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase 1b/2a study designed to evaluate the safety of an investigational product called ATR-04, to reduce the severity of epidermal growth factor receptor inhibitor (EGFRI) associated papulopustular rash on the face. This study will be performed at 10-12 clinical sites, with potentially a virtual component. Approximately 60 eligible subjects will participate. A subject's participation in the study will be up to a maximum of 86 days (up to 28 days for Screening, 28 days of BID treatment, and a 30 day no treatment follow-up period).

The primary objective of this study is to evaluate the safety and tolerability of ATR-04 compared to placebo.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azitra Inc.
• Collaborator: Iqvia Pty Ltd

Criteria

Inclusion Criteria:

• Subject must be at least 18 years of age inclusive, at the time of signing the informed consent

• Subjects with a current diagnosis of cancer

• IGA grade of 0 on the face

• Life expectancy, in the Investigator's opinion, greater than 12 weeks

• Plan to initiate treatment with one of the following EGFRI drugs (other treatments may be considered after consultation with the Sponsor): Cetuximab or Panitumumab or erlotinib

• Able to use Dove sensitive skin body wash for the duration of the treatment period.

• Acceptable and willing to delay start of EGFRI therapy until study eligibility is determined

• Anticipated to continue EGFRI therapy for at least 28 days after the first application of study medication

• Male and/or female

• Contraceptive use by men or women consistent with the EGFRI treatment package insert regarding the methods of contraception for those participating in clinical studies

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol.

Exclusion Criteria:

• Active bacterial skin infections on the face

• Inter-current illness that in the Investigator's opinion puts the subject at undue risk by study participation or interfere with the study conduct or evaluations

• Pregnant women

• EGFRI therapy within the previous 12 weeks

• Radiation therapy exposure to the face within the previous 8 weeks

• Use of topical steroids on the face within the previous 4 weeks

• Use of systemic antibiotics or topical antibiotics on the face in the previous 7 days

• Participation in an investigational clinical study in which administration of an investigational study medication occurred with the previous 30 days