Cutaneous Breast CancerPhase 2NCT05374915
Efficacy and Safety Study of REM-001 Photodynamic Therapy for Treatment of Cutaneous Metastatic Breast Cancer (CMBC)
A Phase 2 study testing REM-001 photodynamic therapy in people with Cutaneous Breast Cancer, run by Kintara Therapeutics, Inc. at 2 sites in United States.
Trial summary
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 trial is to evaluate cutaneous tumor response within total target treatment field to REM-001 therapy assessed using standardized digital photography Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Breast Cancer
- What is being tested?
- REM-001 photodynamic therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Feb 2024to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participants 18 years of age or greater.
- Participants able and willing to sign informed consent.
- Histopathologically confirmed breast cancer metastasis to the skin.
- Cutaneous metastasis not suitable for surgical resection.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Symptomatic lesions (including discomfort, pain, discharge, ulceration).
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- Cutaneous, subcutaneous soft tissue, or superficial lymphatic metastasis that is amenable to PDT:
- Lesion(s) > 10 mm and < 60 mm in longest dimension.
- Lesion(s) exhibit at least one of the following symptoms: ulcerated, bleeding, discharging, itchy, painful.
- Judged by investigator as eligible for PDT.
- Participants are radiotherapy refractory (have received a radiation dose of 60 gray (Gy) or greater to the ipsilateral thorax) or are not otherwise amenable to radiotherapy.
- Disease progression on at least 2 courses of systemic therapy:
- HR positive/HER2 negative participants: should be refractory to endocrine therapy (at least 2 different regimens including at least one CDK4/6 inhibitor). Maintenance endocrine therapy at the clinician's discretion is allowed.
- HER2 positive participants should have had disease progression on at least 2 different regimens of HER2 targeted therapies. Maintenance therapy on trastuzumab (HERCEPTIN®) is allowed.
- If participants are on systemic therapy at enrollment, they must meet the following:
- Participants must have undergone a minimum of two cycles of systemic therapy prior to enrollment.
- The systemic therapy must be one from the Treatment of Physician's Choice (TPC) list, as follows: : eribulin mesylate (Halaven®); capecitabine (Xeloda®); Gemcitabine (Gemzar®); a taxane [either docetaxel (Taxotere®), nab-paclitaxel (Abraxane®), or paclitaxel (Taxol®)]; vinorelbine (Navelbine®); an antibody-drug conjugate [either sacituzumab-govitecan (Trodelvy®), trastuzumab-deruxtecan (Enhertu®), or ado-trastuzumab emtansine (KADCYLA®)]; pembrolizumab (Keytruda®); or carboplatin (Paraplatin®).
- Patients who are not on any chemotherapy will also be eligible.
- At the time of enrolment, participants should have no known plans to change or modify their TPC regimen while receiving study treatment. Note: TPC regimen may be changed or modified after treatment with REM-001 therapy, but this should be done in consultation with the Sponsor Medical Monitor.
- 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.
- Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, hemoglobin ≥ 8.5 g/dL and platelet count ≥ 100 × 10^9/L; INR < 1.5.
- Adequate liver function as evidenced by bilirubin ≤ 2.0 times the upper limits of normal (ULN) and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 3 × ULN (in the case of liver metastases ≤ 5 × ULN) [Participants with known Gilbert's Syndrome who have serum bilirubin < 1.5 x ULN (NCI CTCAE v5.0 Gr 2) may be enrolled].
- QTCF < 470msec on baseline ECG
- Woman of childbearing potential (WOCBP) must have a negative serum pregnancy test documented within 7 days prior to registration and must agree to practice adequate contraception
- 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.
Who cannot join
- Participants who have received local cryotherapy, radiotherapy, intra-lesional chemotherapy, systemic or topical PDT, or surgery to study lesion fields within the past 12 weeks.
- Participants with progressive brain or subdural metastases, or leptomeningeal disease.
- Participants with previously treated brain or subdural metastases may participate provided:
- Previously treated brain metastases are stable and without evidence of progression, as determined by contrast-enhanced CT or MRI brain scan, for at least 4 weeks prior to the first dose of study treatment.
- There is no evidence of new brain metastases
- They have completed local therapy and discontinued the use of corticosteroids for this indication for at least 4 weeks prior to first dose of study treatment.
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- Any neurologic symptoms attributed to brain metastases must have been stable for at least 4 weeks prior to study enrollment
- History of allergic or hypersensitivity reactions to light, egg proteins or egg yolk; history of porphyria, systemic lupus erythematosus, or xeroderma pigmentosum.
- Known disorder of lipoprotein metabolism or clearance (cholesterol> 400 mg/dl, and/or triglycerides > 500 mg/dl).
- 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.
- Participants with inflammatory breast cancer.
- Known human immunodeficiency virus (HIV) infection with detectable virus titer.
- Active or chronic hepatitis B or C infection.
- Active or ongoing infection requiring systemic treatment.
- Participants who have undergone major surgery within 4 weeks of study treatment, or have planned surgery within 4 weeks of anticipated initiation of treatment with REM-001 therapy.
- Participants with otherwise unexplained weight loss (> 10% body weight) in the last 30 days prior to Screening.
- History of other malignancy treated with curative intent within the last 3-5 years. Exceptions are: Curatively treated basal cell/squamous cell skin cancer; carcinoma in situ of the cervix; superficial transitional cell bladder carcinoma
- Patients with other major or uncontrolled medical conditions, e.g., myocardial infarction or New York Heart Association (NYHA) Class III/IV heart failure within the last 6 months, stroke, uncontrolled diabetes, uncontrolled autoimmune disease.
- WOCBP that is pregnant or breast-feeding, or planning to become pregnant or breast-feed during protocol treatment and for 3 months after last dose of REM-001 therapy.
- WOCBP unwilling to use effective contraception during protocol treatment and for 3 months after last dose of REM-001 therapy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Montefiore Einstein Center for Cancer Care
The Bronx, New York, 10467
About this study
Official title: An Open-Labeled, Single Arm Phase 2 Efficacy and Safety Study of REM-001 Photodynamic Therapy (PDT) for Treatment of Cutaneous Metastatic Breast Cancer (CMBC) That is Refractory or Not Eligible for Radiotherapy or Surgery
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 trial is to evaluate cutaneous tumor response within total target treatment field to REM-001 therapy assessed using standardized digital photography
Read the detailed description
All participants must have stable or responding systemic disease for at least 3 months at screening.
REM-001 Therapy:
Day 1: REM-001 = 0.8 mg/kg (IV) at 2 mL/Kg/hr (over approximately 24 minutes)
Day 2: Light treatment per treatment area= 100 J/cm2 (10 min per treatment field) - 24 hrs (± 2 hrs) after infusion of REM-001.
Total area of target lesions treated will be < 200 cm2. Participants will be assessed at week 1, 4, 8, 12, 16, 20 and 24 weeks. An additional 4 weeks follow up will be undertaken if confirmatory assessment is required after week 24.
Assessments will include:
- cutaneous lesion response using photographic imaging
- area of ulceration using photographic imaging
- presence or absence of ulceration, bleeding, discharge and eschar
- patient-reported assessments for pain and itch, using numeric rating scales
- quality of life assessments
- safety On Day 1 of treatment, the participant will undergo an ECG assessment post-infusion and a blood sample for determination of concentration of REM-001 in plasma will be collected post-infusion.
- Conditions
- Cutaneous Breast Cancer
- Being tested
- REM-001 photodynamic therapy
- Keywords
- metastatic, cutaneous
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REM-001 photodynamic therapyCombination product
Infusion of REM-001 (iv) followed by light treatment to treatment field 24 hrs after infusion of REM-001
| Study group | Role | What they receive |
|---|---|---|
| REM-001 photodynamic therapy (PDT) | Experimental | Single arm study. All enrolled patients receive REM-001 therapy Receives: Combination Product: REM-001 photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Overall Objective Response Rate (bORR)
Best Overall Objective Response Rate (bORR) [complete response (CR) or partial response (PR)] of target treatment fields at any time from treatment up to, and including, week 24.
Measured: Up to week 24
Secondary outcomes (17)
Duration of best overall objective response
Duration of best overall objective response (CR or PR) based on initial target fields
Measured: Up to week 24
Time from baseline to the date of the first objective response (PR or CR)
Time from baseline to the date of the first objective response (PR or CR)
Measured: Up to week 24
Change from baseline in area of ulceration
How much the area of ulceration of initial target fields changes from that measured at baseline, when measured by standardized and calibrated digital photography.
Measured: Up to week 24
Change from baseline in area and volume of lesions
How much the area and volume of lesions of initial target fields changes from that measured at baseline when measured by the standardized and calibrated 3D digital photography
Measured: Up to week 24
Change from baseline in lesion discharge
Presence or absence of discharge of cutaneous lesion in initial target treatment field - investigator and independent review of photographs.
Measured: Up to week 24
Change from baseline in lesion bleeding
Presence or absence of bleeding of cutaneous lesion in initial target treatment field - investigator and independent review of photographs.
Measured: Up to week 24
Change from baseline in lesion eschar
Presence or absence of eschar of cutaneous lesion in initial target treatment field - investigator and independent review of photographs.
Measured: Up to week 24
Change from baseline in patient reported assessment of pain
Improvement or worsening of severity of pain using the Brief Pain Inventory-Short Form (BPI-SF) questionnaire over 24 weeks from start of treatment
Measured: Up to week 24
Change from baseline in patient reported assessment of itch
Improvement or worsening of severity of itching using the Pruritus numerical rating scale (NRS) questionnaire over 24 weeks from start of treatment
Measured: Up to week 24
Change from baseline participant-reported overall quality of life
Improvement or worsening over 24 weeks from start of treatment in participant-reported overall quality of life assessed using the EORTC QLQ-C30 (v3.0) questionnaire
Measured: Up to week 24
Investigator-assessed objective response rate (ORR)
Investigator-assessed objective response rate (ORR) over of target treatment fields at any time from treatment up to and including week 24
Measured: Up to week 24
Progression Free Survival (PFS)
Progression Free Survival (PFS) of systemic disease based on RECIST 1.1
Measured: Up to week 24
Overall Survival (OS).
Overall Survival (OS).
Measured: Up to week 24
Adverse events
Incidence and severity of adverse events using CTCAE v5.0 until 24 weeks from treatment
Measured: Up to week 24
Safety assessments
Incidence and severity of clinically significant safety assessments: clinical laboratory examinations, vital signs, and physical exam
Measured: Up to week 24
Electrocardiogram (ECG) - QT interval
The effect of REM-001 therapy on QT interval post-infusion
Measured: Day 1 and 2
Plasma concentrations of REM-001
Determination of plasma concentrations of REM-001 at the end of infusion (15 min post-infusion on day 1) and 24 hrs post-infusion prior to light treatment on day 2
Measured: Day 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start12 Feb 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kintara Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alina Markova, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374915
- Sponsor's protocol ID
- KTI-21-01
- Status last verified
- Nov 2024
- First submitted
- 9 May 2022
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Labeled, Single Arm Phase 2 Efficacy and Safety Study of REM-001 Photodynamic Therapy (PDT) for Treatment of Cutaneous Metastatic Breast Cancer (CMBC) That is Refractory or Not Eligible for Radiotherapy or Surgery
- ClinicalTrials.gov ID
- NCT05374915
- Acronym / sponsor ID
- KTI-21-01
- Conditions
- Cutaneous Breast Cancer
- Keywords
- metastatic, cutaneous
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Kintara Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 trial is to evaluate cutaneous tumor response within total target treatment field to REM-001 therapy assessed using standardized digital photography
Detailed description
All participants must have stable or responding systemic disease for at least 3 months at screening.
REM-001 Therapy:
Day 1: REM-001 = 0.8 mg/kg (IV) at 2 mL/Kg/hr (over approximately 24 minutes)
Day 2: Light treatment per treatment area= 100 J/cm2 (10 min per treatment field) - 24 hrs (± 2 hrs) after infusion of REM-001.
Total area of target lesions treated will be < 200 cm2. Participants will be assessed at week 1, 4, 8, 12, 16, 20 and 24 weeks. An additional 4 weeks follow up will be undertaken if confirmatory assessment is required after week 24.
Assessments will include:
- cutaneous lesion response using photographic imaging
- area of ulceration using photographic imaging
- presence or absence of ulceration, bleeding, discharge and eschar
- patient-reported assessments for pain and itch, using numeric rating scales
- quality of life assessments
- safety On Day 1 of treatment, the participant will undergo an ECG assessment post-infusion and a blood sample for determination of concentration of REM-001 in plasma will be collected post-infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REM-001 photodynamic therapy (PDT) | Experimental | Combination Product: REM-001 photodynamic therapySingle arm study. All enrolled patients receive REM-001 therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Adult participants 18 years of age or greater.
- Participants able and willing to sign informed consent.
- Histopathologically confirmed breast cancer metastasis to the skin.
- Cutaneous metastasis not suitable for surgical resection.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Key exclusion criteria (20 listed)
- Participants who have received local cryotherapy, radiotherapy, intra-lesional chemotherapy, systemic or topical PDT, or surgery to study lesion fields within the past 12 weeks.
- Participants with progressive brain or subdural metastases, or leptomeningeal disease.
- Participants with previously treated brain or subdural metastases may participate provided:
- History of allergic or hypersensitivity reactions to light, egg proteins or egg yolk; history of porphyria, systemic lupus erythematosus, or xeroderma pigmentosum.
- Known disorder of lipoprotein metabolism or clearance (cholesterol> 400 mg/dl, and/or triglycerides > 500 mg/dl).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REM-001 photodynamic therapyInfusion of REM-001 (iv) followed by light treatment to treatment field 24 hrs after infusion of REM-001 | Combination product | REM-001 photodynamic therapy (PDT) |
Primary outcome
Best Overall Objective Response Rate (bORR)
Time frame: Up to week 24
Best Overall Objective Response Rate (bORR) [complete response (CR) or partial response (PR)] of target treatment fields at any time from treatment up to, and including, week 24.
17 secondary outcomes
Duration of best overall objective response
Time frame: Up to week 24
Time from baseline to the date of the first objective response (PR or CR)
Time frame: Up to week 24
Change from baseline in area of ulceration
Time frame: Up to week 24
Change from baseline in area and volume of lesions
Time frame: Up to week 24
Change from baseline in lesion discharge
Time frame: Up to week 24
Change from baseline in lesion bleeding
Time frame: Up to week 24
Change from baseline in lesion eschar
Time frame: Up to week 24
Change from baseline in patient reported assessment of pain
Time frame: Up to week 24
Change from baseline in patient reported assessment of itch
Time frame: Up to week 24
Change from baseline participant-reported overall quality of life
Time frame: Up to week 24
Investigator-assessed objective response rate (ORR)
Time frame: Up to week 24
Progression Free Survival (PFS)
Time frame: Up to week 24
Overall Survival (OS).
Time frame: Up to week 24
Adverse events
Time frame: Up to week 24
Safety assessments
Time frame: Up to week 24
Electrocardiogram (ECG) - QT interval
Time frame: Day 1 and 2
Plasma concentrations of REM-001
Time frame: Day 1 and 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alina Markova, MD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing REM-001 photodynamic therapy in people with Cutaneous Breast Cancer, run by Kintara Therapeutics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Overall Objective Response Rate (bORR) (time frame: Up to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.