REM-001 Photodynamic Therapy for Breast Cancer

Palo Alto (17 mi)

Overseen byAlina Markova, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Kintara Therapeutics, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests REM-001 Therapy, which includes a drug and a light treatment, on patients whose disease is stable or improving. The drug makes cancer cells sensitive to light, helping to destroy them when light is applied.

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

I have symptoms like pain or discharge from my lesions.

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

My skin cancer cannot be removed with surgery.

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

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

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

My condition worsened after two different treatments.

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

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

My breast cancer has spread to my skin.

Exclusion Criteria

I have an ongoing hepatitis B or C infection.

I haven't taken any experimental drugs in the last 4 weeks or within their half-life period.

I have lost more than 10% of my body weight in the last month without trying.

I do not have major uncontrolled health issues like recent heart failure or uncontrolled diabetes.

I have inflammatory breast cancer.

My cholesterol is over 400 mg/dl or my triglycerides are over 500 mg/dl.

My cancer has spread to my brain or its coverings.

I am currently on medication for an infection.

I have HIV with a detectable virus level.

I am not pregnant, breastfeeding, nor planning to become pregnant or breastfeed during and for 3 months after REM-001 therapy.

Treatment Details

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.

1Treatment groups

Experimental Treatment

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

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