Hoth Therapeutics Expands Clinical Trial for Cancer Skin Toxicity Treatment

New Miami site added as demand surges for first-in-class therapy with promising early results

Published on Feb. 25, 2026

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Hoth Therapeutics, a clinical-stage biopharmaceutical company, announced a significant expansion of its CLEER-001 Phase 2a clinical trial for its HT-001 therapy. The company is adding a new enrolling site, Regis Clinical Research in Miami, Florida, to meet the growing patient demand for the treatment, which has shown promising early results in managing the severe skin toxicities that often accompany cancer therapies.

Why it matters

The skin toxicities caused by EGFR inhibitor cancer treatments can be debilitating, forcing up to one-third of patients to reduce or discontinue their life-saving chemotherapy. HT-001 represents a potential breakthrough treatment for this unmet need, as the interim data has shown 100% of patients achieving the primary efficacy endpoint and no dose reductions or discontinuations of cancer therapy required.

The details

The CLEER-001 trial has seen surging patient demand that is outpacing capacity at existing sites. The new Regis Clinical Research site in Miami will provide IRB-approved, FDA-compliant research infrastructure and access to a new patient population in South Florida. Hoth says the expansion is a direct response to the acceleration in enrollment demand, as patients and oncologists take notice of HT-001's promising results, including 100% of open-label cohort patients achieving the primary efficacy endpoint, zero dose-limiting toxicities, and over 65% of patients reporting meaningful reductions in pain and itching.

  • Hoth Therapeutics announced the expansion on February 24, 2026.

The players

Hoth Therapeutics, Inc.

A clinical-stage biopharmaceutical company dedicated to developing innovative treatments to improve patient quality of life.

Regis Clinical Research

A new clinical research site located in Miami, Florida that is joining the CLEER-001 investigational network.

Robb Knie

Chief Executive Officer of Hoth Therapeutics.

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What they’re saying

“The addition of Regis Clinical Research is a direct response to the acceleration we are seeing in enrollment demand. The data speaks for itself. Patients and oncologists are taking notice — and we are building the infrastructure to meet that demand and deliver the full clinical readout this program deserves.”

— Robb Knie, Chief Executive Officer

What’s next

Hoth plans to continue expanding the CLEER-001 investigational site network to meet the growing patient demand for HT-001 as the promising early results generate more interest from patients and oncologists.

The takeaway

HT-001 represents a potential breakthrough treatment for the debilitating skin toxicities that often force cancer patients to reduce or discontinue their life-saving therapies. The surging demand and positive interim data suggest HT-001 could be a game-changer in addressing this significant unmet need in oncology care.