Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REM-001 photodynamic therapy · 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 photodynamic therapy is an investigational small molecule being studied for the treatment of cutaneous breast cancer, specifically cutaneous metastatic breast cancer. It is currently in Phase 2 clinical development by TuHURA Biosciences, Inc. (NASDAQ: HURA).
REM-001 photodynamic therapy is a small molecule modality. The therapy is being evaluated for its efficacy and safety in treating cutaneous metastatic breast cancer. The specific molecular target of REM-001 has not been disclosed in the available clinical trial information.
REM-001 photodynamic therapy is being developed by TuHURA Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol HURA. The company is conducting a Phase 2 clinical trial to evaluate the therapy for cutaneous breast cancer.
REM-001 photodynamic therapy is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA. The ongoing Phase 2 trial is active but not recruiting participants, with an enrollment target of 15 patients.
REM-001 photodynamic therapy is being studied in a Phase 2 clinical trial with the identifier NCT05374915. This trial is titled 'Efficacy and Safety Study of REM-001 Photodynamic Therapy for Treatment of Cutaneous Metastatic Breast Cancer (CMBC)' and is being conducted in the United States. The trial is active but not recruiting, with an enrollment of 15 participants.
REM-001 photodynamic therapy is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for cutaneous breast cancer. The therapy is being evaluated for safety and efficacy, and its approval status has not been established.