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REM-001

Phase 2

Cutaneous Breast Cancer | Small molecule | Oncology |TuHURA Biosciences, Inc.|Last Updated: Aug 28, 2025

Target and mechanism

ModalitySmall molecule

Also known as REM-001 photodynamic therapy

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

REM-001 · 1 trial · 1 indication

Phase 2 1
NCT05374915Efficacy and Safety Study of REM-001 Photodynamic Therapy for Treatment of Cutaneous Metastatic Breast Cancer (CMBC)Cutaneous Breast Cancer
ACTIVE NOT_RECRUITING15 Analytics
PHASE2ACTIVE NOT_RECRUITING
Efficacy and Safety Study of REM-001 Photodynamic Therapy for Treatment of Cutaneous Metastatic Breast Cancer (CMBC)
Cutaneous Breast Cancer
NCT0537491515
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Study Endpoints

Primary Endpoints

Best Overall Objective Response Rate (bORR)
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.

Secondary Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
REM-001 photodynamic therapy (PDT)EXPERIMENTALSingle arm study. All enrolled patients receive REM-001 therapy

Interventions

NameTypeDescription
REM-001 photodynamic therapyCOMBINATION_PRODUCTInfusion of REM-001 (iv) followed by light treatment to treatment field 24 hrs after infusion of REM-001
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

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...

Countries:United States
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