The trial will involve adult cancer patients aged 18 years and above who are currently receiving EGFRI therapy. Credit: Pixel-Shot / Shutterstock.com.

The US Food and Drug Administration (FDA) has approved Hoth Therapeutics to implement significant protocol amendments in its ongoing Phase IIa clinical trial of HT-001.

HT-001 is being developed for patients with cancer who experience skin toxicities caused by epidermal growth factor receptor inhibitors (EGFRIs).

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The randomised, placebo-controlled, double-blind, multicentre dose-ranging trial operates under the company’s active investigational new drug application (IND) for HT-001.

It is designed to assess the safety, efficacy, and tolerability of HT-001 in treating EGFRI-induced skin toxicity.

This trial will involve adult patients aged 18 years and above who are currently receiving EGFRI therapy.

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The trial will be conducted in two parallel cohorts. Part one will be an open-label cohort enrolling 12 patients to assess the pharmacokinetics of the HT-001 gel.

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The part two parallel-arm, randomised study will compare three dose levels of HT-001 gel versus placebo.

In the randomised cohorts, patients will be assigned to one of four treatment arms in a 2:2:2:1 ratio.

Subjects in the open-label and blinded cohorts will use the trial drug once a day on affected areas, including skin, scalp, and nails, with up to 30% body surface area (BSA) involvement.

To identify the minimum efficacious dose strength(s) for further evaluation is the goal of the trial.

The study will also assess the effects of various doses, safety on the application site and therapeutic effects based on primary and secondary goals.

Hoth Therapeutics CEO Robb Knie said: “We are extremely pleased to announce clearance of our clinical trial optimisation 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.”