Spots Global Cancer Trial Database for Efficacy and Safety Study of REM-001 Photodynamic Therapy for Treatment of Cutaneous Metastatic Breast Cancer (CMBC)

Study Description

Brief Summary: This is an open-label, single cohort study to confirm dose, assessments and timing of response, to support future studies. The primary objective of the trial is to evaluate cutaneous tumor response within total target treatment field to REM-001 therapy assessed using standardized digital photography

Detailed Description: All participants must have stable or responding systemic disease for at least 3 months at screening. REM-001 Therapy: Day 1: REM-001 = 0.8 mg/kg (IV) at 2 mL/Kg/hr (over approximately 24 minutes) Day 2: Light treatment per treatment area= 100 J/cm2 (10 min per treatment field) - 24 hrs (± 2 hrs) after infusion of REM-001. Total area of target lesions treated will be \< 200 cm2. Participants will be assessed at week 1, 4, 8, 12, 16, 20 and 24 weeks. An additional 4 weeks follow up will be undertaken if confirmatory assessment is required after week 24. Assessments will include: * cutaneous lesion response using photographic imaging * area of ulceration using photographic imaging * presence or absence of ulceration, bleeding, discharge and eschar * patient-reported assessments for pain and itch, using numeric rating scales * quality of life assessments * safety On Day 1 of treatment, the participant will undergo an ECG assessment post-infusion and a blood sample for determination of concentration of REM-001 in plasma will be collected post-infusion.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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