What is the mechanism of action of this treatment?

Common treatments for breast cancer include surgery, chemotherapy, radiation therapy, hormone therapy, and targeted therapy. Surgery involves physically removing the tumor, while chemotherapy uses drugs to kill rapidly dividing cancer cells. Radiation therapy uses high-energy rays to destroy cancer cells. Hormone therapy blocks hormones like estrogen that fuel certain breast cancers, and targeted therapy attacks specific molecules involved in cancer growth. Photodynamic therapy (PDT), such as REM-001, involves administering a photosensitizing agent that accumulates in cancer cells and is then activated by light to produce reactive oxygen species, leading to cell death. This mechanism is significant for breast cancer patients as it offers a targeted approach that minimizes damage to surrounding healthy tissue, potentially reducing side effects and improving quality of life.

What side effects are associated with this type of intervention?

Common treatments for breast cancer include surgery, chemotherapy, radiation therapy, hormone therapy, and targeted therapy. Each of these treatments has its own set of side effects. For photodynamic therapy (PDT), such as REM-001 therapy, side effects can include localized pain, burning sensation, swelling, redness, and potential blistering at the treatment site. Systemic side effects are generally minimal, but patients may experience photosensitivity, requiring them to avoid direct sunlight for a period after treatment. Other common breast cancer treatments can cause side effects like fatigue, nausea, hair loss, and increased risk of infections.

What prior FDA approvals exist?

Photodynamic therapy (PDT) for cancer treatment involves using a photosensitizing agent activated by light to produce reactive oxygen species that target cancer cells. While REM-001 therapy is being studied for cutaneous metastatic breast cancer, other FDA-approved treatments for breast cancer include chemotherapy agents, hormone therapies, and targeted therapies such as trastuzumab (Herceptin) for HER2-positive breast cancer. Although specific PDT agents for breast cancer may not be widely approved, PDT has been used for other types of cancers, such as esophageal and non-small cell lung cancer, indicating its potential applicability in oncology.

What other types of research exist?

Promising novel alternatives to REM-001 Therapy for breast cancer patients include: 1) Tucatinib-capecitabine-trastuzumab regimen, particularly effective for HER2-positive brain metastases. 2) Fam-trastuzumab deruxtecan (T-DXd), preferred for patients with stable/treated brain metastases and significant extracranial progression. 3) Trastuzumab-emtansine (T-DM1), which has shown a clinical benefit rate of 43% in patients with measurable brain metastases. These therapies have demonstrated significant efficacy and are supported by clinical evidence.

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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

Must not have

Active or chronic hepatitis B or C infection

Participants who have received investigational agents within the past 4 weeks or within 4 half-lives of the investigational agent (whichever is shorter) before the first study drug dose

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 24

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an ongoing hepatitis B or C infection.

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

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

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

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I have inflammatory breast cancer.

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

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My cancer has spread to my brain or its coverings.

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I am currently on medication for an infection.

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I have HIV with a detectable virus level.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best Overall Objective Response Rate (bORR)

Secondary study objectives

Adverse events

Change from baseline in area and volume of lesions

Ulcer

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 23Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include surgery, chemotherapy, radiation therapy, hormone therapy, and targeted therapy. Surgery involves physically removing the tumor, while chemotherapy uses drugs to kill rapidly dividing cancer cells. Radiation therapy uses high-energy rays to destroy cancer cells. Hormone therapy blocks hormones like estrogen that fuel certain breast cancers, and targeted therapy attacks specific molecules involved in cancer growth. Photodynamic therapy (PDT), such as REM-001, involves administering a photosensitizing agent that accumulates in cancer cells and is then activated by light to produce reactive oxygen species, leading to cell death. This mechanism is significant for breast cancer patients as it offers a targeted approach that minimizes damage to surrounding healthy tissue, potentially reducing side effects and improving quality of life.