REM-001 Photodynamic Therapy for Breast Cancer

Not currently recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called REM-001 photodynamic therapy (PDT) for breast cancer that has spread to the skin. The main goal is to evaluate how effectively this therapy shrinks or improves skin tumors, using digital photos to track changes. Participants must have breast cancer that has spread to the skin and cannot be removed by surgery, with symptoms such as pain or discharge. This study targets individuals whose cancer has advanced despite other treatments. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that REM-001 photodynamic therapy is likely to be safe for humans?

Research has shown that REM-001 photodynamic therapy was generally well-tolerated in past studies. A safety database in previous research ensured that side effects were carefully tracked and understood. Although specific side effects were not detailed, the database highlights that safety was a priority in earlier trials.

REM-001 is currently in a Phase 2 trial, indicating it passed initial safety checks in earlier studies. This phase focuses more on the treatment's effectiveness, suggesting that its safety has been sufficiently supported to continue testing. Potential participants should consult their healthcare providers to fully understand the risks and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about REM-001 photodynamic therapy (PDT) for breast cancer because it offers a novel approach compared to traditional treatments like surgery, chemotherapy, and radiation. REM-001 works by using a light-sensitive drug that, once activated by a specific light source, targets and destroys cancer cells with precision, minimizing damage to surrounding healthy tissue. This method not only reduces the potential for side effects but also allows for a targeted attack on cancer cells, which could lead to faster and more effective results. Unlike conventional treatments that often have systemic effects, REM-001's localized action is a promising advancement in breast cancer therapy.

What evidence suggests that REM-001 photodynamic therapy is effective for breast cancer?

Research has shown that REM-001 photodynamic therapy (PDT) could help treat skin-related breast cancer that has spread. This treatment uses a special drug that, when activated by light, targets and destroys cancer cells while sparing nearby healthy tissue. Previous studies have demonstrated its effectiveness for several conditions, including this type of cancer. REM-001 offers advantages over older PDT treatments, suggesting it might be a better option. These findings provide hope for it as a potential treatment for those suffering from this cancer. All participants in this trial will receive REM-001 therapy. ^{1 2 3 4 6}

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. clinicaltrials.gov clinicaltrials.gov/study/NCT05374915

NCT05374915 | Efficacy and Safety Study of REM-001 ... 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 ...

2. targetedonc.com targetedonc.com/view/rem-001-trial-begins-for-cutaneous-metastatic-breast-cancer-treatment

REM-001 Trial Begins for Cutaneous Metastatic Breast ... The agent has multiple advantages over earlier generation PDT compounds and has undergone late-stage clinical development in prior studies.

3. reporter.nih.gov reporter.nih.gov/search/12E0C90B468FC1D47598B8961CAA4A01A2FFCEB861BF/project-details/10877852

Project Details - NIH RePORTER The activated drug destroys tumors with minimal effects to surrounding tissue. REM-001 has been proven to be effective for many conditions, including CMBC.

4. mskcc.org mskcc.org/cancer-care/clinical-trials/23-365

A Phase 2 Study of REM-001 Photodynamic Therapy ... The purpose of this study is to see how well REM-001 works against advanced breast cancer that affects the skin.

5. trialx.com trialx.com/clinical-trials/listings/285029/efficacy-and-safety-study-of-rem-001-photodynamic-therapy-for-treatment-of-cutaneous-metastatic-breast-cancer-cmbc/

Efficacy and Safety Study of REM-001 Photodynamic ... Overview. This is an open-label, single cohort study to confirm dose, assessments and timing of response, to support future studies.

6. clinicaltrialsarena.com clinicaltrialsarena.com/news/kintara-trial-breast-cancer/

Kintara commences trial of REM-001 for breast cancer REM-001 has so far demonstrated a clinical efficacy rate of 80% complete responses in evaluable CMBC lesions and has a safety database from ...