RECRUITING

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

Conditions

Acneiform Eruption Due to Chemical Xerosis Cutis Paronychia Acneiform rash EGFR inhibitor Cutaneous toxicities

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn about HT-001 Topical Gel for treatment of EGFR inhibitor-induced skin toxicities. The main questions it aims to answer are: * Determine the therapeutic effect of HT-001 for treatment of patients who develop acneiform rash undergoing Epidermal Growth Factor inhibitor (EGFRI) therapy using the acneiform rash investigator's global assessment scale \[ARIGA\] * Evaluate the safety of HT-001 during treatment Participants will apply HT-001 Gel once per day for 6 weeks, during which the effect on treating acneiform rash or other skin disorders induced by EGFRI therapy will be evaluated using different assessment tools to measure severity of rash, pain, and itching (pruritus), as well as the change in quality of life. The study will be completed in 2 periods: the first period is open-label (unblinded) and all patients will receive HT-001 topical gel with the active ingredient; the second period is blinded and patients will be randomized to receive one of three concentrations of HT-001 or placebo. Researchers will compare HT-001 to the placebo in the second period to see if HT-001 provides a significant treatment effect.

Official Title

A Randomized, Placebo-controlled, Parallel Phase 2a Dose-ranging 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

Quick Facts

Study Start:2023-07-19

Study Completion:2025-01-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05639933

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Adult patient (ie, ≥ 18 years of age at Screening/Baseline \[V1\]) prescribed an approved EGFRI to treat cancer (indication within the approved labeling for the EGFRI). 2. Patient has developed a rash or symptoms of a rash (papular and/or pustular eruptions) or symptoms of a rash (cutaneous burning), as assessed by both Common Terminology Criteria for Adverse Events (CTCAE) grading and ARIGA scales (severity 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 4. Predicted life expectancy ≥ 3 months. 5. Patient is able and willing to comply with contraceptive requirements. 6. Patient must have the ability and willingness to attend the necessary visits (telehealth and in person). 7. Patient must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.	1. Patient has severe cutaneous toxicity (severity = 4 on the CTCAE grading and ARIGA scales) or cutaneous toxicity involvement that is \> 30% BSA, or other severe systemic toxicity (severity \> 3 on the CTCAE v5.0 scale) as a result of EGFRI therapy. 2. Patient has any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the patient would comply with the protocol or complete the study per protocol. 3. Patient has a history of other skin disorders (eg, atopic dermatitis, psoriasis, recurrent skin infections), or history of illness that, in the opinion of the Investigator, would confound results of the study or pose unwarranted risk in administering study drug to the patient. 4. Patient has abnormal laboratory values at Screening/Baseline (V1): 1. Absolute neutrophil count \< 1000/mm3 and WBC count \< 3000/mm3 2. Platelet count \< 50,000/mm3 3. Aspartate transaminase (AST) \> 2.5 × upper limit of normal (ULN) 4. Alanine transaminase (ALT) \> 2.5 × ULN 5. Bilirubin \> 1.5 × ULN 6. Creatinine \> 1.5 × ULN 5. Patient has a prescribed cancer treatment plan that requires radiation treatment to the head, neck, or upper trunk concurrent with EGFRI therapy or has previously received radiation therapy within 4 weeks prior to Screening/Baseline (V1). 6. Patient has received aprepitant or other neurokinin-1 receptor antagonist within 4 weeks prior to Screening/Baseline (V1). 7. Patient has had prior treatment with an investigational drug within 4 weeks prior to Screening/Baseline (V1), or at least 8 half-lives of the drug, whichever is longer. 8. Patient has an active infection (eg, pneumonia) or any uncontrolled disease except for the malignancy that, in the opinion of the Investigator, might confound the result or the study or pose unwarranted risk in administering the study drug to the patient. 9. Patient has received non-stable escalating doses of topical antibiotics, topical steroids, or other topical treatments within 14 days prior to Screening/Baseline (V1). Patients who have been on stable doses of topical antibiotics, topical steroids, or other topical treatments for 14 days or more are allowed to be enrolled and to stay on their current prescription. Reduction in dose due to improvement in EGFRI-related toxicities is allowed. 10. Patient has used non-stable escalating doses of systemic steroids within 14 days prior to Screening/Baseline (V1) excluding low-dose systemic corticosteroids as part of standard of care for prevention or treatment of chemotherapy-induced nausea and vomiting; acceptability of the steroid and dose is to be determined by the study Investigator. Patients who have been on a stable dose of systemic steroids for 14 days or more are allowed to be enrolled and to stay on their current prescription. Reduction in dose due to improvement in EGFRI-related toxicities is allowed. Use of steroid inhalers and nasal corticosteroids is allowed. 11. Patient has received non-stable escalating dose treatment with a systemic antibiotic within 14 days prior to Screening/Baseline (V1). Patients who have been on stable doses of systemic antibiotics for 14 days or more are allowed to be enrolled and to stay on their current prescription. Reduction in dose due to improvement in EGFRI-related toxicities is allowed. 12. Patient has received concomitant treatment with pimozide, moderate to strong cytochrome p450 (CYP) 3A4 inhibitors (diltiazem, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir), or strong CYP3A4 inducers (rifampin, carbamazepine, phenytoin) within 30 days of Screening/Baseline (V1). 13. Patient has a history of hypersensitivity to aprepitant or any component of HT-001. 14. Patient is pregnant or lactating at Screening/Baseline (V1) or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.

Inclusion Criteria

Exclusion Criteria

1. Adult patient (ie, ≥ 18 years of age at Screening/Baseline \[V1\]) prescribed an approved EGFRI to treat cancer (indication within the approved labeling for the EGFRI).
2. Patient has developed a rash or symptoms of a rash (papular and/or pustular eruptions) or symptoms of a rash (cutaneous burning), as assessed by both Common Terminology Criteria for Adverse Events (CTCAE) grading and ARIGA scales (severity
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
4. Predicted life expectancy ≥ 3 months.
5. Patient is able and willing to comply with contraceptive requirements.
6. Patient must have the ability and willingness to attend the necessary visits (telehealth and in person).
7. Patient must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.

1. Patient has severe cutaneous toxicity (severity = 4 on the CTCAE grading and ARIGA scales) or cutaneous toxicity involvement that is \> 30% BSA, or other severe systemic toxicity (severity \> 3 on the CTCAE v5.0 scale) as a result of EGFRI therapy.
2. Patient has any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the patient would comply with the protocol or complete the study per protocol.
3. Patient has a history of other skin disorders (eg, atopic dermatitis, psoriasis, recurrent skin infections), or history of illness that, in the opinion of the Investigator, would confound results of the study or pose unwarranted risk in administering study drug to the patient.
4. Patient has abnormal laboratory values at Screening/Baseline (V1):
1. Absolute neutrophil count \< 1000/mm3 and WBC count \< 3000/mm3
2. Platelet count \< 50,000/mm3
3. Aspartate transaminase (AST) \> 2.5 × upper limit of normal (ULN)
4. Alanine transaminase (ALT) \> 2.5 × ULN
5. Bilirubin \> 1.5 × ULN
6. Creatinine \> 1.5 × ULN
5. Patient has a prescribed cancer treatment plan that requires radiation treatment to the head, neck, or upper trunk concurrent with EGFRI therapy or has previously received radiation therapy within 4 weeks prior to Screening/Baseline (V1).
6. Patient has received aprepitant or other neurokinin-1 receptor antagonist within 4 weeks prior to Screening/Baseline (V1).
7. Patient has had prior treatment with an investigational drug within 4 weeks prior to Screening/Baseline (V1), or at least 8 half-lives of the drug, whichever is longer.
8. Patient has an active infection (eg, pneumonia) or any uncontrolled disease except for the malignancy that, in the opinion of the Investigator, might confound the result or the study or pose unwarranted risk in administering the study drug to the patient.
9. Patient has received non-stable escalating doses of topical antibiotics, topical steroids, or other topical treatments within 14 days prior to Screening/Baseline (V1). Patients who have been on stable doses of topical antibiotics, topical steroids, or other topical treatments for 14 days or more are allowed to be enrolled and to stay on their current prescription. Reduction in dose due to improvement in EGFRI-related toxicities is allowed.
10. Patient has used non-stable escalating doses of systemic steroids within 14 days prior to Screening/Baseline (V1) excluding low-dose systemic corticosteroids as part of standard of care for prevention or treatment of chemotherapy-induced nausea and vomiting; acceptability of the steroid and dose is to be determined by the study Investigator. Patients who have been on a stable dose of systemic steroids for 14 days or more are allowed to be enrolled and to stay on their current prescription. Reduction in dose due to improvement in EGFRI-related toxicities is allowed. Use of steroid inhalers and nasal corticosteroids is allowed.
11. Patient has received non-stable escalating dose treatment with a systemic antibiotic within 14 days prior to Screening/Baseline (V1). Patients who have been on stable doses of systemic antibiotics for 14 days or more are allowed to be enrolled and to stay on their current prescription. Reduction in dose due to improvement in EGFRI-related toxicities is allowed.
12. Patient has received concomitant treatment with pimozide, moderate to strong cytochrome p450 (CYP) 3A4 inhibitors (diltiazem, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir), or strong CYP3A4 inducers (rifampin, carbamazepine, phenytoin) within 30 days of Screening/Baseline (V1).
13. Patient has a history of hypersensitivity to aprepitant or any component of HT-001.
14. Patient is pregnant or lactating at Screening/Baseline (V1) or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.

Contacts and Locations

Study Contact

Hayley Springer

CONTACT

646-756-2997

hayley@hoththerapeutics.com

Principal Investigator

Mario Lacouture, MD

STUDY_CHAIR

NYU Langone Health

Study Locations (Sites)

UC Irvine - Chao Family Cancer Center

Orange, California, 92868

United States

The George Washington University Medical Faculty Associates

Washington, District of Columbia, 20037

United States

University of Miami

Miami, Florida, 33125

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Washington University in St Louis School of Medicine

Saint Louis, Missouri, 63110

United States

Montefiore Medical Center

Bronx, New York, 10467

United States

NYU Langone Health

Mineola, New York, 11501

United States

Northwell Physician Partners Dermatology

New Hyde Park, New York, 11042

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Hoth Therapeutics, Inc.

Mario Lacouture, MD, STUDY_CHAIR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-19

Study Completion Date2025-01-29

Study Record Updates

Study Start Date2023-07-19

Study Completion Date2025-01-29

Terms related to this study

Keywords Provided by Researchers

Acneiform rash
EGFR inhibitor
Cutaneous toxicities

Additional Relevant MeSH Terms

Acneiform Eruption Due to Chemical
Xerosis Cutis
Paronychia