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PRT3789

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment135

FDA Designations

No designations recorded

Clinical trial landscape

PRT3789 · 1 trial · 4 indications

Phase 1 1
NCT05639751PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 MutationAdvanced Solid Tumor
COMPLETED135 Analytics
PHASE1COMPLETED
PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation
Advanced Solid TumorUnlock trial analytics

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 to 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 (matched to "Advanced Solid Tumor")

Frequently asked questions about PRT3789

What is PRT3789 used for?

PRT3789 is an investigational small molecule being developed for the treatment of advanced solid tumors, including metastatic solid tumors and non-small cell lung cancers. It is specifically being studied in patients whose tumors carry a SMARCA4 gene mutation. The drug is currently in Phase 1 clinical development.

What does PRT3789 target?

PRT3789 is being studied in patients with SMARCA4 gene mutations. The drug is designed to target tumors that harbor this specific genetic alteration, which is a key focus of its clinical development program in advanced solid tumors.

Who makes PRT3789?

PRT3789 is being developed by Prelude Therapeutics Incorporated, a biopharmaceutical company listed on the stock exchange under the ticker symbol PRLD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced solid tumors.

What phase is PRT3789 in?

PRT3789 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing clinical program is evaluating the drug as a monotherapy and in combination with docetaxel for advanced solid tumors.

What clinical trials is PRT3789 in?

PRT3789 is being studied in clinical trial NCT05639751, titled 'PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation.' This Phase 1 trial has enrolled 135 participants and has been completed. The study was conducted in the United States, France, Netherlands, Singapore, and Spain.

Is PRT3789 being tested in combination with other drugs?

Yes, PRT3789 is being evaluated both as a monotherapy and in combination with docetaxel. The clinical trial NCT05639751 is investigating these treatment approaches in patients with advanced or metastatic solid tumors that have a SMARCA4 gene mutation.