Clinical trial

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

Name

23-PP-04

Description

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

Trial arms

Trial start

2024-02-16

Estimated PCD

2024-12-01

Trial end

2025-12-01

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

Experimental : 5 Day treatment course 1 with Tirbanibulin Ointment 1%

Other names:

Tirbaso

Size

Primary endpoint

Incidence of Treatment-Emergent Adverse Events

up to 17 months

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-Arm, Open-Label, Single Center', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2024-03-18

1 organization

1 product

1 indication

Organization

Centre Hospitalier Universitaire de Nice

Product

Tirbanibulin

Indication

Squamous Cell Carcinoma