A Phase 2, Single-Arm, Open-Label, Single Center Study to Assess Efficacy and Safety of Tirbanibulin Ointment 1% in Adult Subjects With Superficial Basal Cell Carcinoma (sBCC) on the Neck, Trunk, or Extremities (Excluding Axilla, Anogenital, and Face/Scalp)

AICR-BCC-01

This is a Phase 2, Single-Arm, Open-Label, Single Center, Proof of Concept Study to Assess Efficacy and Safety of Tirbanibulin Ointment 1% in Adult Subjects with superficial basal cell carcinoma (sBCC) on the neck, trunk, or extremities (excluding, axilla, anogenital, and face/scalp).

2023-04-17

2023-12-10

2024-04-15

Recruiting

Early phase I

10

Inclusion Criteria: 1. Males and females ≥ 18 years old. 2. Willingness and ability to sign the informed consent form and Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent form and a HIPAA form must be obtained in writing for all subjects prior to starting any study procedures. 3. Present of 1 naïve sBCC on the neck, trunk, or extremities (excluding, axilla, anogenital, and face/scalp) that: * is between 6 and 20mm in greatest diameter * \>2cm from a hairline * Must lack any evidence of aggressive growth patterns (e.g., severe squamous metaplasia, infiltrative/desmoplastic features, or basosquamous features) 4. sBCC assessed as non-naïve (e.g., previously treated, or recurrent) or non-eligible by biopsy and at least 5cm away from an eligible lesion should be excised or treated with Electrodesiccation and Curettage (ED\&C) in a timely manner. 5. Free of significant physical abnormalities (e.g., tattoos, dermatoses) within the potential treatment area plus a 5cm radius surrounding the lesion as they may interfere with examination or final evaluation, in the opinion of the investigator. 6. Willingness to stop the use of moisturizers, sunscreens, and any other cosmetics within the treatment area plus a 5cm radius from screening until final the visit. 7. Willingness to abstain from sunbathing or the use of artificial tanning from screening until the final visit. Subjects with a sunburn in the treatment area cannot be included until fully recovered. 8. Subjects must be healthy or have a medical condition that is stable in the opinion of the investigator. 9. Females must be postmenopausal (\>45 years of age with at least 12 months of amenorrhea), surgically sterile (by hysterectomy, bilateral oophorectomy, or tubal ligation); or, if of childbearing potential, must be using highly effective contraception for at least 30 days or 1 menstrual cycle, whichever is longer, prior to study treatment and must agree to continue to use highly effective contraception for at least 30 days following their last dose of study treatment. Highly effective contraception includes oral hormonal contraceptives, hormonal contraceptive implant, injection or patch, intrauterine device, or complete abstinence from sexual intercourse. 10. Sexually active males who have not had a vasectomy, and whose partner is reproductively capable, must agree to use barrier contraception from Screening through 90 days after their last dose of study treatment. Exclusion Criteria: 1. Location of the treatment area is: * On face, scalp, anogenital, axillae * Within 5 cm of an incompletely healed wound * Within 2 cm of hairline 2. Anticipated need for in-patient hospitalization or in-patient surgery from Day 1 to Day 57. 3. Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for Actinic Keratosis (AK) within the treatment area or within 2 cm of the treatment area, within 8 weeks prior to the Screening visit. 4. Use of the following therapies and/or medications within 2 weeks prior to the Screening visit: * Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the treatment area or within 2 cm of the selected treatment area * Acid-containing therapeutic products (e.g., salicylic acid or fruit acids, such as alpha and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within the treatment area or within 2 cm of the selected treatment area * Topical salves or topical steroids within the treatment area or within 2 cm of the selected treatment area * Artificial tanners within the treatment area or within 5 cm of the selected treatment area 5. Use of the following therapies and/or medications within 4 weeks prior to the Screening visit: * Treatment with immunomodulators (e.g., azathioprine), cytotoxic drugs (e.g., cyclophosphamide, vinblastine, chlorambucil, methotrexate) or interferons/interferon inducers * Treatment with systemic medications that suppress the immune system (e.g., cyclosporine, prednisone, methotrexate, alefacept, infliximab) * Use of systemic retinoids (e.g., isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit 6. A history of sensitivity and/or allergy to any of the ingredients in the study medication. 7. A skin disease (e.g., atopic dermatitis, psoriasis, eczema) or condition (e.g., scarring, open wounds) that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the subject to unacceptable risk by study participation. 8. Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the subject to unacceptable risk by study participation. 9. Females who are pregnant or nursing. 10. Participated in an investigational drug trial during which an investigational study medication was administered within 30 days or 5 half-lives of the investigational product, whichever is longer, before dosing. 11. In the opinion of the investigator, are unable or unlikely to comply with the administration schedule and study evaluations.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Open Label Study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}

2023-06-22