HT-001 for Skin Side Effects from Cancer Therapy

(CLEER Trial)

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen by Milan J Anadkat, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Hoth Therapeutics, Inc.

Must be taking: EGFR inhibitors

Must not be taking: Neurokinin-1 antagonists, CYP3A4 inhibitors

Disqualifiers: Severe toxicity, Skin disorders, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications if they are stable. If you are on stable doses of topical or systemic antibiotics, steroids, or other treatments for 14 days or more, you can continue them. However, certain medications like pimozide, some antibiotics, and specific enzyme inhibitors or inducers should not be taken within 30 days before starting the trial.

How is the drug HT-001 different from other treatments for skin side effects from cancer therapy?

HT-001 is a topical gel specifically designed to address skin side effects from cancer therapy, which may offer a more targeted approach compared to systemic treatments. Unlike some treatments that can enhance radiation side effects, HT-001 aims to alleviate them, potentially providing a novel option for patients experiencing skin toxicity.

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Eligibility Criteria

This trial is for adults over 18 with cancer, who are starting EGFRI treatment within 4 weeks and have developed a rash or symptoms of it. They must be able to consent, attend visits, expect to live at least 3 months, follow contraceptive rules, and have an ECOG status of 0-2. Excluded are those with less than 8-week EGFRI therapy plan, recent radiation to head/neck/trunk, active infections or uncontrolled diseases that could affect the study's outcome.

Inclusion Criteria

I can and will attend all required visits, both in person and via telehealth.

I am an adult prescribed an EGFRI for my cancer treatment.

Predicted life expectancy ≥ 3 months

Exclusion Criteria

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

Patient has a history of hypersensitivity to aprepitant or any component of HT-001

Patient has abnormal laboratory values at Screening/Baseline (V1): Absolute neutrophil count < 1000/mm3 and WBC count < 3000/mm3, Platelet count < 50,000/mm3, AST > 2.5 × ULN, ALT > 2.5 × ULN, Bilirubin > 1.5 × ULN, Creatinine > 1.5 × ULN

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Treatment

Participants receive HT-001 2% Gel to measure pharmacokinetics

6 weeks

Daily application

Randomized Treatment

Participants are randomized to receive one of three concentrations of HT-001 or placebo

6 weeks

Daily application

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

Participant Groups

The trial tests HT-001 Topical Gel in various concentrations (0.5%, 1%, and 2%) against a placebo for treating skin toxicities caused by EGFR inhibitors in cancer patients. It has two phases: an open-label phase where all receive HT-001 and a blinded phase where participants get either the gel or placebo randomly.

Group I: Open-Label PK Cohort Experimental Treatment 1 Intervention

Topical treatment with HT-001 2% Gel unblinded.

Group II: Randomized, Double Blind Cohort Placebo Group 4 Interventions

Topical treatment with HT-001 (2%, 1%, or 0.5%) or placebo (HT-001 vehicle), blinded

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Dana Farber Cancer Institute Boston, MA

UC Irvine - Chao Family Cancer Center Orange, CA

Perlmutter Cancer Center at NYU Langone Long Island Surgical Oncology Associates Mineola, NY

UCI Health - CIACC Irvine, CA

More Trial Locations

Who Is Running the Clinical Trial?

Hoth Therapeutics, Inc. Lead Sponsor

Worldwide Clinical Trials Collaborator

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Topical Nanoemulgel for the Treatment of Skin Cancer: Proof-of-Technology. [2021] The present study is a mechanistic validation of 'proof-of-technology' for the effective topical delivery of chrysin nanoemulgel for localized, efficient treatment of melanoma-affected skin.

2. England pubmed.ncbi.nlm.nih.gov

Enhanced radiation sensitivity and radiation recall dermatitis (RRD) after hypericin therapy -- case report and review of literature. [2021] Modern radiotherapy (RT) reduces the side effects at organ at risk. However, skin toxicity is still a major problem in many entities, especially head and neck cancer. Some substances like chemotherapy provide a risk of increased side effects or can induce a "recall phenomenon" imitating acute RT-reactions months after RT. Moreover, some phototoxic drugs seem to enhance side effects of radiotherapy while others do not. We report a case of "radiation recall dermatitis" (RRD) one year after RT as a result of taking hypericin (St. John's wort).

3. New Zealand pubmed.ncbi.nlm.nih.gov

Women's experience of acute skin toxicity following radiation therapy in breast cancer. [2022] Acute skin toxicity is experienced by 70%-100% of patients receiving radiation therapy following breast cancer. Most studies focus on skin appearances and treatment of such reactions, not the experience. Increased knowledge about patients' experience will contribute to provide tailored patient care. Thus, the purpose was to investigate patients' experiences of acute skin toxicity following radiation therapy for breast cancer.

4. United States pubmed.ncbi.nlm.nih.gov

Topical Cream Carrying Drug-Loaded Nanogels for Melanoma Treatment. [2023] In this study, nanogel creams carrying paclitaxel (PTX) and temozolomide (TMZ) were prepared for the topical treatment of melanoma. PTX and TMZ were first loaded in poly-(D,L-lactide-co-glycolide)-block-poly(ethylene glycol)-block-poly-(D,L-lactide-co-glycolide) (PLAG-b-PEG-b-PLGA) thermosensitive nanogels, which made a transition from a free-flowing sol (formation of micellar network) at 25°C with the z-average particle size of c.a. 96 nm to a gel (aggregation of micelles) at 33°C with the z-average particle size of c.a. 427 nm. An anhydrous absorption ointment base, aquaphor, was then added to drug-loaded nanogels to form nanogel creams carrying PTX and TMZ. Nanogel creams permitted controlled release of the payloads and improved the penetration of the payloads through the rodent skin compared to drug(s)-loaded nanogels. PTX and TMZ in a combination were synergistically effective in inhibiting SK-MEL28, A375, and B16-F10 melanoma cancer cells in vitro. Topically applied nanogel creams carrying TMZ/PTX (4 mg/1.5 mg/dose) showed a trend of tumor volume inhibition on B16-F10-bearing xenograft mice in vivo.

5. Germany pubmed.ncbi.nlm.nih.gov

Novel hyaluronan formulation for preventing acute skin reactions in breast during radiotherapy: a randomized clinical trial. [2020] We conducted a randomized, double-blind, vehicle-controlled clinical trial to investigate the use of a new proprietary hyaluronan (HA) formulation for the prevention of acute skin toxicity in breast cancer patients undergoing radiotherapy (RT).