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Also known as REM-001 photodynamic therapy
REM-001 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| REM-001 photodynamic therapy (PDT) | EXPERIMENTAL | Single arm study. All enrolled patients receive REM-001 therapy |
| Name | Type | Description |
|---|---|---|
| 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 |
Inclusion Criteria: * 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...
REM-001 is being developed for the treatment of cutaneous metastatic breast cancer, meaning breast cancer that has spread to the skin. It is an investigational photodynamic therapy given to patients with these skin lesions. It has not been approved by the FDA and remains in clinical development.
REM-001 is being developed by TuHURA Biosciences, Inc., which trades under the ticker HURA. The company is running the clinical program for this photodynamic therapy asset in cutaneous metastatic breast cancer, with one active Phase 2 study listed in the United States.
REM-001 is in Phase 2 clinical development. Its single registered trial, NCT05374915, is a Phase 2 study that is currently active and not recruiting. The program has not completed any trials and REM-001 is not FDA approved.
REM-001 is being studied in NCT05374915, titled Efficacy and Safety Study of REM-001 Photodynamic Therapy for Treatment of Cutaneous Metastatic Breast Cancer (CMBC). The Phase 2 trial is active but not recruiting, is enrolling 15 patients in the United States, and is uncontrolled, open-label, and restricted to adults 18 years and older.
Yes. REM-001 photodynamic therapy is another name for REM-001, the same investigational asset from TuHURA Biosciences. Both names refer to the small molecule therapy being tested in Phase 2 for cutaneous metastatic breast cancer under trial NCT05374915.
Yes, REM-001 is a biomarker-selected therapy, meaning its Phase 2 trial in cutaneous metastatic breast cancer enrolls patients based on a defined biomarker rather than an unselected population. The study NCT05374915 is active but not recruiting and has a planned enrollment of 15 patients.