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
Sponsor study identifier
interventional
15
1 country
2
Study Start
February 12, 2024
Actual (reported)Primary Completion
December 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 9, 2022
Actual (reported)May 16, 2022
Actual (reported)February 12, 2024
Actual (reported)December 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Best Overall Objective Response Rate (bORR)
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.
Up to week 24
Duration of best overall objective response
Up to week 24
Time from baseline to the date of the first objective response (PR or CR)
Up to week 24
Change from baseline in area of ulceration
Up to week 24
Change from baseline in area and volume of lesions
Up to week 24
Change from baseline in lesion discharge
Up to week 24
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Montefiore Einstein Center for Cancer Care
The Bronx, New York, 10467, United States
Alina Markova, MD
Memorial Sloan Kettering Cancer Center
First Submitted
May 9, 2022
First Posted
May 16, 2022
Study Start
February 12, 2024
Actual (reported)Primary Completion
December 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 28, 2025
Record last verified: 2024-11
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Source: ClinicalTrials.gov.
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