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Photosensitizer

REM-001 Photodynamic Therapy for Breast Cancer

Phase 2

Recruiting

Led By Alina Markova, MD

Research Sponsored by Kintara Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate renal function, as evidenced by estimated glomerular filtration rate (eGFR) > 45 mL/min/1.73 m2 using the CKD-EPI Creatinine Equation without race

Male patients must be sterile or willing to use an approved method of contraception from the time of treatment with REM-001 until 90 days after study drug treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 24

Awards & highlights

Study Summary

This trialevaluates how well a new therapy (REM-001) works to reduce skin tumors. Photos are taken to measure response.

Who is the study for?

This trial is for adults with breast cancer that has spread to the skin, causing symptoms like pain or ulceration. Participants must have tried at least two systemic therapies and be on certain treatments for 3 months. They should not be suitable for surgery or radiation therapy, have stable brain metastases if present, no major recent surgeries or other serious medical conditions, and agree to use contraception.Check my eligibility

What is being tested?

The study tests REM-001 photodynamic therapy in patients with cutaneous metastatic breast cancer. It's an open-label trial aiming to confirm dosing and timing of response using digital photography to evaluate how well skin tumors respond to this treatment.See study design

What are the potential side effects?

While specific side effects are not listed here, photodynamic therapy can generally cause reactions at the treatment site such as redness, swelling, and pain; sensitivity to light; itching; changes in skin pigmentation; and possibly mild fever.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is good, with an eGFR over 45.

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I am a male willing to use contraception during and up to 90 days after treatment.

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I can take care of myself and am up and about more than half of my waking hours.

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I have symptoms like pain or discharge from my lesions.

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I have had radiation of 60 Gy or more to my chest or cannot receive radiation.

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My skin cancer cannot be removed with surgery.

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My lesion is either ulcerated, bleeding, discharging, itchy, or painful.

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My HER2 positive cancer progressed despite treatment with specific HER2 targeted therapies.

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I have skin or shallow lymph cancer spots between 10mm and 60mm big.

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My condition worsened after two different treatments.

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I have been on a specific cancer treatment for at least 3 months.

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My blood tests show normal white blood cells, hemoglobin, and platelets.

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My breast cancer has spread to my skin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best Overall Objective Response Rate (bORR)

Secondary outcome measures

Adverse events

Change from baseline in area and volume of lesions

Ulcer

+14 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: REM-001 photodynamic therapy (PDT)Experimental Treatment1 Intervention

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

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kintara Therapeutics, Inc.Lead Sponsor

4 Previous Clinical Trials

1,179 Total Patients Enrolled

Alina Markova, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

7 Previous Clinical Trials

832 Total Patients Enrolled

1 Trials studying Breast Cancer

50 Patients Enrolled for Breast Cancer

Media Library

REM-001 (Photosensitizer) Clinical Trial Eligibility Overview. Trial Name: NCT05374915 — Phase 2

Breast Cancer Research Study Groups: REM-001 photodynamic therapy (PDT)

Breast Cancer Clinical Trial 2023: REM-001 Highlights & Side Effects. Trial Name: NCT05374915 — Phase 2

REM-001 (Photosensitizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05374915 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is REM-001 photodynamic therapy (PDT) a safe and efficient treatment for patients?

"As the study has yet to confirm efficacy, REM-001 photodynamic therapy (PDT) was given a safety rating of 2. Nonetheless, there is some evidence which supports its security from prior clinical data."

Answered by AI

Are enrollments for this experiment still open presently?

"Unfortunately, this clinical trial is not actively recruiting patients. Although initially posted on the first of July 2023 and most recently updated in November 2022, it does not appear to be searching for candidates at present. Fortunately though, there are 2287 other trials currently welcoming volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Efficacy and Safety Study of REM-001 Photodynamic Therapy for Treatment of Cutaneous Metastatic Breast Cancer (CMBC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05374915.

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