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PRT3789

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Prelude Therapeutics Incorporated|Last Updated: Oct 16, 2025

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment135
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05639751PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 MutationPHASE1 COMPLETED 135 — — May 2, 2023Oct 1, 2025Oct 16, 202532 United States, France +3
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Study Endpoints
Primary Endpoints
Dose limiting toxicity (DLT) of PRT3789 monotherapy and in combination with docetaxel
Baseline through Day 21

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

Safety and tolerability of PRT3789 monotherapy and in combination with docetaxel: AEs, CTCAE Assessments
Baseline through approximately 3 years

Safety and tolerability will be evaluated by incidence of DLTs, laboratory measurements, dose interruption, modification, and discontinuation due to adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

Maximum tolerated dose (MTD)/ Recommended phase 2 dose (RP2D) of PRT3789 monotherapy and in combination with docetaxel
Baseline through approximately 3 years

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

Secondary Endpoints
Efficacy of PRT3789 monotherapy and in combination with docetaxel: Objective response rate (ORR)
Baseline through approximately 3 years
Efficacy of PRT3789 monotherapy and in combination with docetaxel: Progression-free survival (PFS)
Baseline through approximately 3 years
Efficacy of PRT3789 monotherapy and in combination with docetaxel: Clinical benefit rate (CBR)
Baseline through approximately 3 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PRT3789 MonotherapyEXPERIMENTALPRT3789 will be administered by intravenous infusion
PRT3789/Docetaxel CombinationEXPERIMENTALPRT3789 and Docetaxel will be administered by intravenous infusions
Interventions
NameTypeDescription
PRT3789DRUGPRT3789 will be administered by intravenous infusion
DocetaxelDRUGDocetaxel will be administered by intravenous infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites32

Inclusion Criteria: * Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures * Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy with any mut...

Countries:United StatesFranceNetherlandsSingaporeSpain
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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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