Efficacy and Safety Study of REM-001 Photodynamic Therapy for Treatment of Cutaneous Metastatic Breast Cancer (CMBC)

NCT05374915 | Active Not Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: KTI-21-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Cutaneous Breast Cancer

Keywords

metastatic; cutaneous

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to week 24

Secondary Outcomes (17)

• Duration of best overall objective response

  Up to week 24

• Time from baseline to the date of the first objective response (PR or CR)

  Up to week 24

• Change from baseline in area of ulceration

  Up to week 24

• Change from baseline in area and volume of lesions

  Up to week 24

• Change from baseline in lesion discharge

  Up to week 24

Study Arms (1)

REM-001 photodynamic therapy (PDT)

EXPERIMENTAL

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

Combination Product: REM-001 photodynamic therapy

Interventions

REM-001 photodynamic therapy COMBINATION_PRODUCT

Infusion of REM-001 (iv) followed by light treatment to treatment field 24 hrs after infusion of REM-001

REM-001 photodynamic therapy (PDT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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:

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Kintara Therapeutics, Inc.: lead

Study Sites (2)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Montefiore Einstein Center for Cancer Care

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alina Markova, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 16, 2022
• Study Start: February 12, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 28, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)