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PRT2527

Phase 1

Sarcoma | Small molecule | Oncology |Prelude Therapeutics Incorporated|Last Updated: Dec 11, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05159518A Study of PRT2527 in Participants With Advanced Solid TumorsPHASE1 COMPLETED 30Feb 14, 2022Dec 6, 2023Dec 11, 20238 United States
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Study Endpoints
Primary Endpoints
Dose limiting toxicities (DLT) of PRT2527
Baseline through Day 21

Dose limiting toxicities will be evaluated over the 21-day observation period

Maximally tolerated dose (MTD) of PRT2527
Baseline through approximately 1 year

The MTD will be established for further investigation in participants with advanced solid tumors

Recommended phase 2 dose (RP2D) and schedule of PRT2527
Baseline through approximately 1 year

The RP2D will be established for further investigation in participants with advanced solid tumors

Secondary Endpoints
Safety and tolerability of PRT2527: AEs, SAEs, CTCAE assessments
Baseline through approximately 2 years
Pharmacokinetic profile of PRT2527: maximum observed plasma concentration
Baseline through approximately 1 year
Anti-tumor activity of PRT2527: measurement of objective responses
Baseline through approximately 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PRT2527EXPERIMENTALPRT2527 will be administered by intravenous infusion
Interventions
NameTypeDescription
PRT2527DRUGPRT2527 will be administered by intravenous infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Tumor types under study 1. Selected sarcomas with a documented gene fusion 2. Castrate resistant prostate cancer (CRPC) 3. Hormone receptor positive (HR+), HER2 negative (HER2-) breast cancer 4. Non-small cell lung cancer (NSCLC) 5. MYC amplified solid tumors * Must...

Countries:United States
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