REM-001 Photodynamic Therapy for Breast Cancer

Recruiting at 1 trial location

Overseen By John Langlands, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kintara Therapeutics, Inc.

Must be taking: Endocrine therapy, HER2 therapies

Must not be taking: Corticosteroids, Investigational agents

Disqualifiers: Brain metastases, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 24 weeks

15 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial does not specify that you must stop taking your current medications. However, if you are on systemic therapy, it should be from a specific list of approved treatments, and you should not plan to change this regimen while receiving the study treatment.

How is REM-001 Photodynamic Therapy different from other breast cancer treatments?

REM-001 Photodynamic Therapy is unique because it uses light to activate a special drug that targets and destroys cancer cells, making it a minimally invasive option. This approach is particularly promising for aggressive forms of breast cancer like inflammatory breast cancer, where traditional targeted therapies are lacking. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment REM-001 Photodynamic Therapy for Breast Cancer?

Photodynamic therapy (PDT) has shown promise in treating various types of cancer, including breast cancer, by using light to activate a special drug that targets and destroys cancer cells. Studies have indicated that PDT can be effective for patients with breast cancer recurrence, especially when combined with other treatments like radiotherapy. ^{2 4 6 7 8}

Who Is on the Research Team?

Alina Markova, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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

The investigator has determined that you are suitable for photodynamic therapy (PDT).

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.

Exclusion Criteria

I stopped using corticosteroids for my condition 4 weeks before starting the study treatment.

I have an ongoing hepatitis B or C infection.

I have not had certain local treatments on my cancer in the last 12 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 months

Treatment

Participants receive REM-001 photodynamic therapy, including an infusion and light treatment

24 weeks

Visits at week 1, 4, 8, 12, 16, 20, and 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• REM-001

Trial Overview 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.

How Is the Trial Designed?

Group I: REM-001 photodynamic therapy (PDT) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Kintara Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

1,200+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Photodynamic therapy--an alternative pathway in the treatment of recurrent breast cancer. [2019]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

A pilot randomized clinical study of the additive treatment effect of photodynamic therapy in breast cancer patients with chest wall recurrence. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Molecular, cellular, and tissue responses following photodynamic therapy. [2019]

4. Denmark pubmed.ncbi.nlm.nih.gov

Photodynamic therapy--coming of age. [2007]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Photodynamic therapy for chest wall recurrence from breast cancer. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Photodynamic therapy as an effective therapeutic approach in MAME models of inflammatory breast cancer. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Optimal light dose and drug dosage in the photodynamic treatment using PHOTOCYANINE. [2021]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[PHOTODYNAMIC THERAPY FOR INTRADERMAL METASTASES OF BREAST CANCER USING THE MATRIX LIGHT-EMITTING DIODES APPARATUS LATUS]. [2015]