Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma (Tirbaso)

Open, Prospective Study Evaluating the Efficacy and Safety of 0.05% Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma

his is a Phase 2, Single-Arm, Open-Label, Single Center, to Assess Efficacy and Safety of Tirbanibulin Ointment 1% in Adult Subjects with superficial basal cell carcinoma (sBCC) not arising on the face or scalp

Study Overview

• Status: Recruiting
• Conditions: Cell Carcinoma
• Intervention / Treatment: Drug: Tirbanibulin

Detailed Description

This is a pilot study aimed at studying the efficacy and tolerance of a new topical treatment regimen in BCC. The number of 50 sBCC to be treated was established based on previous studies that have investigated the effectiveness of a topical regimen in sBCC. Considering that approximately 10% of BCCs will be wrongly included or not evaluable or will present with a deviation protocol major, a total of 55 sBCC will be included in the study.Inclusion Criteria :

• Age > 18 years
• Histologically confirmed, primary, previously untreated, superficial basal cell carcinoma (sBCC) not arising on the face or scalp, ≤ 15 mm (large axis)

Exclusion Criteria :

• BCC of the face or scalp
• BCC of non-superficial subtype
• BCC with large axis > 15mm
• Relapsing BCC
• Allergy to treatment
• Treatment with cryotherapy, imiquimod, PDT, or radiotherapy in the BCC area during the 6 months prior to the screening visit. Visits : 1) Selection visit = V0: if the patient meets the selection criteria, oral and written information will be given to him. If the patient signs the consent during this consultation, the inclusion visit will be carried out at the same time. 2) Inclusion visit and start of treatment = V1 (D1): for patients who have not signed their consent at the previous visit, consent will be collected • Verification of inclusion and non-inclusion criteria • Collection of medical and surgical history • Collection of previous and concomitant treatments • Clinical evaluation by visual inspection: measurement of the long axis, calculation of the surface to be treated (maximum treated surface for all sBCC should not exceed > 25 cm2) • Realization of a layer with the limits of the lesion • Clinical photos • Examination by LC-OCT • Dispensing of Tirbanibulin for the treatment cycle (1 tube for up to 3 sBCC) • Explanation of the mode of application to the patient • First application performed on site • Giving the patient a notebook to record the applications of the product and local skin reactions. 3) Follow-up visit +/- retreatment = V2 (D28 ± 2 d) • Collection of adverse events and changes in concomitant treatments • Collection of local skin reactions in the patient notebook • Evaluation of local skin reactions • Clinical evaluation and by LC-OCT -> In case of cure clinically and by LC-OCT (complete remission, CR) end of the study for the patient -> In the absence of CR processing as in V1 -> in case of a wound at the application site, the study will end for the patient and he will be treated according to standard recommendantions for• sBCC 4) Additional follow-up visits +/- retreatment = V3 (D56±2 days), V4 (D84+/-2d) : these visits will be conducted identically to V2. 5) Short-term efficacy visit = V5 (D112 +/- 2d): same as V2 w/o treatment with Tirbanibulin. Patients not in CR will terminate the study and will be treated according to standard recommendations for sBCC. 6) Long-term efficacy visit = V6 (M12): same as V2 w/o treatment with Tirbanibulin. All patients will terminate the study. Patients with relapse of their BCC will be treated according to standard recommendations for sBCC.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Philippe Bahadoran, PhD; Phone Number: +33492036223; Email: bahadoran.p@chu-nice.fr
• Study Contact Backup: Name: Henri Montaudie, PhD; Phone Number: +33492036223

Study Locations

• France
  • Alpes-maritimes
    • Nice, Alpes-maritimes, France, 06200
      • Recruiting
      • CHU de Nice - Hôpital de l'Archet
      • Contact: Philippe Bahadoran, PhD; Phone Number: +33492036223; Email: bahadoran.p@chu-nice.fr
      • Principal Investigator: Philippe Bahadoran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age > 18 years
• Histologically confirmed,
• primary, previously untreated,
• superficial basal cell carcinoma (sBCC) not arising on the face or scalp, ≤ 15 mm (large axis)

Exclusion Criteria:

• BCC of the face or scalp
• BCC of non-superficial subtype
• BCC with large axis > 15mm
• Relapsing BCC
• Allergy to treatment
• Treatment with cryotherapy, imiquimod, PDT, or radiotherapy in the BCC area during the 6 months prior to the screening visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental : 5 Day treatment course 1 with Tirbanibulin Ointment 1%; Subjects will be given one study kit containing single-dose packets of Tirbanibulin Ointment 1% and instructed to topically apply to the treatment area once daily for 5 consecutive days. Subjects with unresolved lesion at d28 or d56 or d72 or d84 will be given an additional study kit containing single-dose packets of Tirbanibulin Ointment 1% and instructed to topically apply to the treatment area once daily for 5 consecutive days.

Drug: Tirbanibulin; Subjects will be given one study kit containing single-dose packets of Tirbanibulin Ointment 1% and instructed to topically apply to the treatment area once daily for 5 consecutive days. Subjects with unresolved lesion at d28 or d56 or d72 or d84 will be given an additional study kit containing single-dose packets of Tirbanibulin Ointment 1% and instructed to topically apply to the treatment area once daily for 5 consecutive days.; Other Names: Tirbaso

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	IMC	up to 17 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0	Type, frequency, severity and time to onset of adverse effects. Adverse effects will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) scale. Local adverse effects will be assessed by the LSR score.	up to 17 months
Number of Participants With complete remission	Complete remission after the 1st, 2nd, 3rd or 4th cycle of Tirbanibulin (Klisiry®) in sBCC.	After the treatment at 17 months
Number of participants with sBCC thickness.	sBCC thickness assessed	Baseline visit

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: philippe Bahadoran, PhD, CHU de Nice, Service de Dermatologie

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: TIRBANIBULIN
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Tirbanibulin
• Other Study ID Numbers: 23-PP-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No