Study on the Effectiveness and Safety of REM-001 Light Therapy for Treating Skin Metastases from Breast Cancer

Sponsor: Kintara Therapeutics, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05374915

Provider View

This clinical trial is testing a new light-based treatment, REM-001, to see if it can effectively treat skin metastases in breast cancer patients. The study will use digital photography to assess how well the treatment works on skin tumors.

Patient Parameters

Program Overview

This study aims to evaluate the effectiveness of REM-001, a light-based therapy, in treating skin metastases from breast cancer. Participants will receive the treatment and be monitored over several weeks to see how their skin tumors respond. The study will use digital photography to track changes in the tumors and assess any side effects or improvements in symptoms like pain and itchiness.

Description

Participants in this study will receive REM-001 therapy, which involves an intravenous infusion followed by light treatment. On the first day, participants will receive an infusion of REM-001. The next day, light treatment will be applied to the affected skin areas. The total area treated will be less than 200 cm². Participants will be evaluated at various intervals up to 24 weeks, with an additional follow-up if needed. Assessments will include photographic imaging of skin lesions, checking for symptoms like ulceration or bleeding, and patient-reported measures of pain and itch. Quality of life and safety will also be monitored. On the first day of treatment, participants will have an ECG and a blood test to measure REM-001 levels.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Able and willing to sign informed consent.
  • Confirmed breast cancer that has spread to the skin.
  • Skin metastases not suitable for surgery.
  • ECOG performance status of 0 to 2.
  • Symptomatic skin lesions (e.g., pain, discharge).
  • Skin lesions suitable for light therapy, measuring between 10 mm and 60 mm.
  • Lesions must show symptoms like ulceration or pain.
  • Not responsive to radiotherapy or not suitable for it.
  • Disease progression after at least two systemic therapies.
  • Stable or responding systemic disease for at least 3 months.
  • Adequate kidney, bone marrow, and liver function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Men must be sterile or agree to use contraception during and after treatment.

Exclusion Criteria

  • Recent local treatments to the study area within 12 weeks.
  • Progressive brain or subdural metastases.
  • Allergies to light, egg proteins, or certain medical conditions.
  • High cholesterol or triglycerides.
  • Recent use of investigational drugs.
  • Inflammatory breast cancer.
  • Active HIV, hepatitis B, or C infections.
  • Recent major surgery or planned surgery soon.
  • Significant unexplained weight loss recently.
  • Other recent cancers, except certain skin or cervical cancers.
  • Major uncontrolled medical conditions.
  • Pregnant or breastfeeding women, or those planning to become pregnant or breastfeed soon.
  • Women unwilling to use contraception during and after treatment.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.