All participants will be receiving their Treatment of Physician's Choice for systemic disease and have stable disease for at least 12 weeks.~REM-001 Therapy:~Day 1: REM-001 = 0.8 mg/kg (IV) at 2 mL/Kg/hr (over34pprox.x. 25 min) 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.
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