FDA Expands HT-001 Trial to Include Cancers With EGFR-Associated Toxicities


Following clearance from the FDA, Hoth Therapeutics is carrying out a clinical trial as part of its open investigational new drug program for HT-001 in cancers undergoing toxicities from EGFR inhibition.

  • A clinical trial (NCT05639933) has been granted clearance from the FDA to expand and evaluate HT-001 for the treatment of patients with cancer undergoing treatment of skin toxicities associated with EGFR inhibitors (EGFRi).

  • HT-001 has demonstrated a promising safety profile among patients with cancer affected by EGFRi.

  • Under its open investigational new drug application (IND) for HT-001, Hoth Therapeutics is conducting this phase 2a trial.
Cancer cells, malignant cells, generative ai illustration: © Dr_microbe - stock.adobe.com

Cancer cells, malignant cells, generative ai illustration: © Dr_microbe - stock.adobe.com

About the Phase 2a Study of HT-001

Trial Name: 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

ClinicalTrials.gov Identifier: NCT05639933

Sponsor: Hoth Therapeutics, Inc.

Recruitment Contact: Hayley Springer, 646-756-2997, hayley@hoththerapeutics.com

Completion Date: January 29, 2025

The FDA has cleared the implementation of a number of protocol amendments for an ongoing trial evaluating HT-001 for the treatment patients with cancer undergoing treatment of skin toxicities associated with EGFRi, according to Holt Therapeutics, Inc.1

"We are extremely pleased to announce clearance of our clinical trial optimization plan for HT-001. Armed with positive initial data and a clean safety profile to date, we believe that these protocol amendments could ultimately result in the generation of a highly compelling data set which could support patients suffering from the effects of EGFRi cancer treatment. These latest developments underscore Hoth Therapeutics' continued commitment to delivering a safe and effective treatment for this very underserved patient population," said Robb Knie, chief executive officer of Hoth Therapeutics, in a press release.1

The randomized, double-blind, placebo-controlled, multicenter trial is being conducted under the IND for HT-001 by Hoth Therapeutics. The phase 2a trial is a dose-ranging study where investigators will assess the efficacy, safety, and tolerability of HT-001 for treatment of EGFRi-induced skin toxicity.

Patients aged 18 years and older who are receiving EGFRi therapy, have an estimated life expectancy ≥ 3 months, and have an ECOG performance status of 0-2 will be enrolled in 1 of 2 parallel cohorts and randomized to receive 1 of the 4 treatment arms.2 In part 1 of the trial, the open-label portion, 12 patients will be included and investigators will measure the pharmacokinetics of HT-001 gel. In part 2, the randomized, parallel arm study, 3 dose levels of HT-001 gel will be compared with placebo (HT-001 vehicle).

In both open-label and blinded cohorts of the study, all patients will apply the study drug to each of the affected areas once a day with cutaneous toxicity up to 30% body surface area involvement, inclusive of skin, scalp, and nails.

Determining the minimum efficacious dose strengths for further investigation serves at the main goal of the study. Dose effect, application site safety assessments, and therapeutic effects will also be evaluated based on the primary and secondary end points.

The trial has an estimated study completion date of January 29, 2025, and plans to enroll approximately 152 patients. Sites in Florida, Missouri, and Texas are actively recruiting patients.

1. Hoth Therapeutics announces it received FDA approval to expand HT-001 clinical trial to treat severely Ill patients. News release. Hoth Therapeutics, Inc. January 18, 2024. January 18, 2024. http://tinyurl.com/y8sm7hxv
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 (CLEER). ClinicalTrials.gov. Updated September 11, 2023. Accessed January 18, 2024. https://clinicaltrials.gov/study/NCT05639933
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