A Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma

NCT05157763 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: MW2020-11-26
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

This study will be a multicenter, prospective, open label, one-arm study intended to assess the Safety and Efficacy of EscharEx (EX-02) in the treatment of Basal Cell Carcinoma. In patients with one primary superficial or nodular basal cell carcinoma lesion with a diameter of 5-10mm (Histologically confirmed BCC) located on the trunk or upper extremities (not including the hands), with well-defined borders and no previous radiation therapy.

Conditions

Superficial Basal Cell Carcinoma; Nodular Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (5)

• Incidence and severity of treatment-emergent AEs (TEAEs) and serious TEAEs (STEAEs).

  All adverse events (AEs) will be listed. Adverse events records will include notification whether the AE is local and occurs near or in the target lesion. The AEs will be listed as counts and percentages by System Organ Class (SOC), Preferred Term (PT), severity, and time of onset. Serious Adverse Events will be analyzed in the same way as AEs

  Through study completion - an average of 16 weeks

• Vital signs - proportion of patients with abnormal clinical significant measurements

  Assessed pre 2nd, pre 5th application and post last application

  Up to completion of treatment period - up to 5 weeks

• Pain assessments- Proportion of patients with clinical significant elevation in NPRS score

  Assesed pre 2nd, pre 5th application and post last application compared with pre 1st application

  Up to completion of treatment period - up to 5 weeks

• Proportion of subjects discontinuing a treatment due to TEAEs, assessed over the entire course of the treatment.

  This proportion will be calculated, together with its 95% confidence interval based on the binomial distribution.

  Up to completion of treatment period - up to 5 weeks

• Proportion of subjects that requested to discontinue the treatment

  This will be assessed over the entire course of the treatment and will be calculated, together with its 95% confidence interval based on the binomial distribution

  Up to completion of treatment period - up to 5 weeks

Secondary Outcomes (2)

• Proportion of patients who reached complete histological clearance at the end of the post treatment period.

  Up to 13 weeks

• Proportion of patients who reached complete clearance at the end of the post treatment period, as clinically assessed prior to surgical removal.

  Up to 13 weeks

Study Arms (1)

EscharEx 5%

EXPERIMENTAL

The powder of EX-02 (4 g per vial) should be reconstituted with 10 ml water for injection (WFI) to obtain 5% EX-02 gel. The EX-02 powder and the WFI are to be mixed up to 15 min prior to use. EX-02 5% gel will be topically applied in a thick layer of 2-3 mm on the lesion surface including margin of 5-10 mm for 8-12 hours (preferable over-night) and covered with an occlusive dressing. A new vial should be used for each application. Each patient will be treated with 7 applications.

Drug: EscharEx 5% (EX-02 formulation)

Interventions

EscharEx 5% (EX-02 formulation) DRUG

EX-02 5% will be topically applied in a thick layer of 2-3 mm on the lesion surface for 8-12 hours including 5-10 mm margins and covered with an occlusive dressing. A new vial should be used for each application. Each patient will be treated with 7 applications.

Also known as: EX-02 5%

EscharEx 5%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female greater than age 18,
• Patients with one primary superficial or nodular basal cell carcinoma lesion (Histologically confirmed BCC) located on the trunk or upper extremities (not including the hands), with well-defined borders and no previous radiation therapy.
• Lesion is present for no longer than 4 years.
• Lesion with a diameter of 5-10mm,
• Patient and/or legally authorized representative (LAR) understands the nature of the procedure, is able and willing to adhere to the protocol regimen, and able to provide a written informed consent prior to any study procedure.

You may not qualify if:

• Evidence of Gorlin syndrome, neoplastic diseases (except actinic lesions), metastatic tumor or tumor with high probability of metastatic spread,
• Other malignant cancers (non BCC) of the skin at the lesion's site,
• Morphea-type basal cell carcinoma (MBCC) at the lesion's site (per biopsy report),
• Any signs of infection at the lesion site including purulent discharge, tissue abscess, erysipelas, cellulitis, etc.,
• Patients with any dermatological disease in the target lesion site or surrounding area (not including chronic actinic damage in the surrounding area),
• History of allergy or atopic disease or a known sensitivity to pineapples, papaya, bromelain or papain, as well as known sensitivity to latex proteins (known as latex-fruit syndrome), bee venom or olive tree pollen,
• Patients undergoing renal or peritoneal dialysis,
• Any condition that would preclude safe participation in the study, e.g. evidence of significant or unstable cardiovascular, pulmonary, liver, hematological, immunological, or any immediate life threatening condition,
• Concurrent acute injury or disease that might compromise the patient's welfare or the participation in the study,
• Current (within last 12 months) severe alcohol or drug use disorder
• Pregnant women (positive blood or urine pregnancy test) or nursing mothers,
• Exposure to investigational intervention within 4 weeks prior to enrolment, or anticipated participation in another investigational drug trial or other intervention trial, while enrolled in the study.

Sponsors & Collaborators

• MediWound Ltd: lead

Study Sites (3)

Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

RECRUITING

Moore Clinical Research, Inc.

Brandon, Florida, 33511, United States

NOT YET RECRUITING

Center for Clinical Studies, LTD. LLP

Webster, Texas, 77598, United States

RECRUITING

Study Officials

• Lior Rosenberg, Prof.

  MediWound Ltd

  STUDY DIRECTOR

Central Study Contacts

Limor Dinur Klein, PhD

CONTACT

972779714000; limord@mediwound.com

Keren David, MSc

CONTACT

kerend@mediwound.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: December 15, 2021
• Study Start: June 30, 2021
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)