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PRT1419

Phase 1

Multiple Myeloma | Small molecule | Oncology |Prelude Therapeutics Incorporated|Last Updated: Nov 15, 2022

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 Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04543305A Study of PRT1419 in Patients With Relapsed/Refractory Hematologic MalignanciesPHASE1 COMPLETED 16Sep 28, 2020Mar 21, 2022Nov 15, 20225 United States
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Study Endpoints
Primary Endpoints
To describe dose limiting toxicities (DLT) of PRT1419
Baseline through Day 28

Dose limiting toxicities will be evaluated through the first cycle

To determine the maximally tolerated dose (MTD) and/or optimal biological dose (OBD)
Baseline through approximately 2 years

The MTD and/or OBD will be established for further investigation in participants with multiple myeloma, Non-Hodgkin's Lymphoma, acute myeloid leukemia and myelodysplastic syndrome

To determine the recommended phase 2 dose (RP2D) and schedule of PRT1419
Baseline through approximately 2 years

The RP2D will be established for further investigation in participants with multiple myeloma, Non-Hodgkin's Lymphoma, acute myeloid leukemia and myelodysplastic syndrome

Secondary Endpoints
To describe the adverse event profile and tolerability of PRT1419
Baseline through approximately 2 years
To describe the pharmacokinetic profile of PRT1419
Baseline through approximately 2 years
To describe any anti-tumor activity of PRT1419
Baseline through approximately 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PRT1419EXPERIMENTALPRT1419 will be administered orally
Interventions
NameTypeDescription
PRT1419DRUGPRT1419 will be administered orally
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 * Adequate organ function (bone marrow, hepatic, renal, cardiovascular) * Left ventricular ejection fraction of ≥50% * Female patients of childbearing potential must have a negative pregnancy test within 7 day...

Countries:United States
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Competitive Landscape -Multiple Myeloma 228 trials
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Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Eli Lilly and CompanyLLY1PHASE1LOXO-338, Pirtobrutinib
Moderna, Inc.MRNA2PHASE1mRNA-2808
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