Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05374915 | Efficacy and Safety Study of REM-001 Photodynamic Therapy for Treatment of Cutaneous Metastatic Breast Cancer (CMBC) | PHASE2 | ACTIVE NOT_RECRUITING | 15 | — | — | Feb 12, 2024 | Dec 31, 2025 | Aug 28, 2025 | 2 | United States |
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...