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PRT811

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Prelude Therapeutics Incorporated|Last Updated: Apr 5, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment86
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04089449A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and GliomasPHASE1 COMPLETED 86Nov 6, 2019Mar 28, 2023Apr 5, 202311 United States
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Study Endpoints
Primary Endpoints
To describe dose limiting toxicities (DLT) of PRT811
Baseline through Day 21

Dose limiting toxicities will be evaluated through the first cycle

To determine the maximally tolerated dose (MTD)
Baseline through approximately 2 years

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

To determine the recommended phase 2 dose (RP2D) and schedule of PRT811
Baseline through approximately 2 years

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

Secondary Endpoints
To describe the adverse event profile and tolerability of PRT811
Baseline through approximately 2 years
To describe the pharmacokinetic profile of PRT811
Cycle 1 (each cycle is 21 days) on Days 1, 8 and 14. For subsequent cycles, Day 1 of each cycle through the end of study treatment, an average of 6 months
To describe any anti-tumor activity of PRT811
Baseline through approximately 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PRT811EXPERIMENTALPRT811 will be administered orally
Interventions
NameTypeDescription
PRT811DRUGPRT811 will be administered orally
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Malignancies that are refractory to or intolerant of established therapies known to provide clinical benefit for the malignancy in question, or in the opinion of the Investigator, not be a candidate for such therapies * Subjects must have recovered from the effects of any prio...

Countries:United States
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