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PRT543

Phase 1

Relapsed/Refractory Advanced Solid Tumors | Small molecule | Oncology |Prelude Therapeutics Incorporated|Last Updated: Mar 28, 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 Enrollment232
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03886831A Study of PRT543 in Participants With Advanced Solid Tumors and Hematologic MalignanciesPHASE1 COMPLETED 232 — — Feb 11, 2019Nov 16, 2022Mar 28, 202323 United States
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Study Endpoints
Primary Endpoints
To describe dose limiting toxicities (DLT) of PRT543
Baseline through Day 28.

Dose limiting toxicities (DLTs) will be evaluated during the first cycle

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

The maximum tolerated dose (MTD) will be established for further investigation in participants with advanced malignancies who have failed prior treatments.

To determine the recommended phase 2 dose (RP2D) and schedule of PRT543
Baseline through approximately 2 years.

The recommended phase 2 dose (RP2D) and optimal dosing schedule of PRT543 will be established for further investigation in participants with advanced malignancies who have failed prior treatments.

Secondary Endpoints
To describe the adverse event profile and tolerability of PRT543
Baseline through approximately 2 years
To determine the maximum observed plasma concentration (Cmax) of PRT543
Cycle 1 (each cycle is 28 days) on Days 1, 15, and/or 25: predose and 0.5, 1, 2, 4, 8, 24 hours postdose; predose on Cycle 1, Days 3, 4, 8, 11, and/or 22. Subsequently for Cycle 2 and beyond (until end of study treatment) on Day 1.
To determine the time to reach maximum observed plasma concentration (Tmax) of PRT543
Cycle 1 (each cycle is 28 days) on Days 1, 15, and/or 25: predose and 0.5, 1, 2, 4, 8, 24 hours postdose; predose on Cycle 1, Days 3, 4, 8, 11, and/or 22. Subsequently for Cycle 2 and beyond (until end of study treatment) on Day 1.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PRT543EXPERIMENTALPRT543 will be administered orally
Interventions
NameTypeDescription
PRT543DRUGPRT543 will be administered orally
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * Metastatic or advanced solid tumor; or advanced diffuse large B-cell lymphoma; or advanced mantle cell lymphoma; or relapsed myelodysplastic syndrome, acute myeloid leukemia or chronic myelomonocytic leukemia; or relapsed myelofibrosis. All malignancies must be refractory to e...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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