Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Single arm study. All enrolled patients receive REM-001 therapy

Infusion of REM-001 (iv) followed by light treatment to treatment field 24 hrs after infusion of REM-001

REM-001 photodynamic therapy

Manahil Sadiq, MHA

John Langlands, PhD

Alina Markova, MD

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

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.

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

An Open-Labeled, Single Arm Phase 2 Efficacy and Safety Study of REM-001 Photodynamic Therapy (PDT) for Treatment of Cutaneous Metastatic Breast Cancer (CMBC) That is Refractory or Not Eligible for Radiotherapy or Surgery

Best Overall Objective Response Rate (bORR) \[complete response (CR) or partial response (PR)\] of target treatment fields at any time from treatment up to, and including, week 24.

Duration of best overall objective response (CR or PR) based on initial target fields

Time from baseline to the date of the first objective response (PR or CR)

How much the area of ulceration of initial target fields changes from that measured at baseline, when measured by standardized and calibrated digital photography.

How much the area and volume of lesions of initial target fields changes from that measured at baseline when measured by the standardized and calibrated 3D digital photography

Presence or absence of discharge of cutaneous lesion in initial target treatment field - investigator and independent review of photographs.

Presence or absence of bleeding of cutaneous lesion in initial target treatment field - investigator and independent review of photographs.

Presence or absence of eschar of cutaneous lesion in initial target treatment field - investigator and independent review of photographs.

Improvement or worsening of severity of pain using the Brief Pain Inventory-Short Form (BPI-SF) questionnaire over 24 weeks from start of treatment

Improvement or worsening of severity of itching using the Pruritus numerical rating scale (NRS) questionnaire over 24 weeks from start of treatment

Improvement or worsening over 24 weeks from start of treatment in participant-reported overall quality of life assessed using the EORTC QLQ-C30 (v3.0) questionnaire

Investigator-assessed objective response rate (ORR) over of target treatment fields at any time from treatment up to and including week 24

Progression Free Survival (PFS) of systemic disease based on RECIST 1.1

Incidence and severity of adverse events using CTCAE v5.0 until 24 weeks from treatment

Incidence and severity of clinically significant safety assessments: clinical laboratory examinations, vital signs, and physical exam

The effect of REM-001 therapy on QT interval post-infusion

Determination of plasma concentrations of REM-001 at the end of infusion (15 min post-infusion on day 1) and 24 hrs post-infusion prior to light treatment on day 2

Spots Global Cancer Trial Database for cutaneous breast cancer