NCT05374915

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Kintara Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cutaneous Breast Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	REM-001 photodynamic therapy	Infusion of REM-001 (iv) followed by light treatment to treatment field 24 hrs after infusion of REM-001

Timeline

• Start date: 2024-02-12
• Primary completion: 2025-12-30
• Completion: 2025-12-31
• First posted: 2022-05-16
• Last updated: 2025-08-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study