> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/prt3789-monotherapy-and-in-combo-w-docetaxel-in-participants-5d17d056-bff8-42b1-a73a-6f5db9d28e0e > Record changed: 2026-11-04 # PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation NCT05639751 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) Participants 135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) Lead sponsor Prelude Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) Start date 2023-05-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) Number of sites 32 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) ## Title and summary **Summary** This is a Phase 1 dose-escalation study of PRT3789, a SMARCA2 degrader, in participants with advanced or metastatic solid tumors with loss of SMARCA4 due to truncating mutation and/or deletion. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of PRT3789 monotherapy and in combination with docetaxel, describe any dose limiting toxicities (DLTs), define the dosing schedule, and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) to be used in subsequent development of PRT3789. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) **Short title** PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) **Official title** A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3789 as Monotherapy and in Combination With Docetaxel in Participants With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) ## Dates **Completion date** 2025-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) **First posted** 2022-12-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) **Registry last updated** 2025-10-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) **Primary completion date** 2025-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) **Start date** 2023-05-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) ## Size and sites **Actual participants** 135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) **Participants** 135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) **Number of sites** 32 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) **Lead sponsor** Prelude Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) ## Identifiers **Registry ID** NCT05639751 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) **ClinicalTrials.gov ID** NCT05639751 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) ## Outcomes ### Primary outcomes 1. Dose limiting toxicity (DLT) of PRT3789 monotherapy and in combination with docetaxel Timeframe: Baseline through Day 21 Dose limiting toxicities will be evaluated over the 21-day observation period 2. Safety and tolerability of PRT3789 monotherapy and in combination with docetaxel: AEs, CTCAE Assessments Timeframe: 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) 3. Maximum tolerated dose (MTD)/ Recommended phase 2 dose (RP2D) of PRT3789 monotherapy and in combination with docetaxel Timeframe: Baseline through approximately 3 years The MTD/RP2D will be established for further investigation in participants with advanced solid tumors ### Secondary outcomes 1. Efficacy of PRT3789 monotherapy and in combination with docetaxel: Objective response rate (ORR) Timeframe: Baseline through approximately 3 years Best overall response of either complete response (CR) or partial response (PR), as assessed by the investigator per RECIST v1.1 2. Efficacy of PRT3789 monotherapy and in combination with docetaxel: Progression-free survival (PFS) Timeframe: Baseline through approximately 3 years Duration from Day 1 to the earliest date of first disease progression, as assessed by the investigator per RECIST v1.1, discontinuation because of disease progression, or death due to any cause 3. Efficacy of PRT3789 monotherapy and in combination with docetaxel: Clinical benefit rate (CBR) Timeframe: Baseline through approximately 3 years Best overall response of CR, PR, or durable stable disease (24 weeks or longer duration), as assessed by the investigator per RECIST v1.1 4. Efficacy of PRT3789 monotherapy and in combination with docetaxel: Duration of response (DOR) Timeframe: Baseline through approximately 3 years Duration from time of first observed response (CR or PR) to the earliest date of disease progression, as assessed by the investigator per RECIST v1.1, or death due to any cause 5. Pharmacokinetic profile of PRT3789 monotherapy and in combination with docetaxel: Maximum observed plasma concentration Timeframe: Baseline through approximately 3 years Pharmacokinetics will be calculated including the maximum observed plasma concentration 6. Pharmacokinetic profile of PRT3789 monotherapy and in combination with docetaxel: Area under the curve Timeframe: Baseline through approximately 3 years Pharmacokinetics will be calculated including the area under the plasma concentration versus time curve (AUC) 7. Pharmacodynamic effect of PRT3789 monotherapy and in combination with docetaxel: Target engagement Timeframe: Baseline through approximately 3 years Pharmacodynamic effect of PRT3789 monotherapy and in combination with docetaxel demonstrating target engagement by assessment of SMARCA2 protein in peripheral blood mononuclear cells (PBMCs) and tumor tissue Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 mutation of SMARCA4 (dose escalation and combination cohorts) and loss of function mutation of SMARCA4 (backfill cohorts) by local testing that have either progress on or ineligible for standard of care therapy - Must have measurable or non-measureable (but evaluable) disease per RECIST v1.1 for dose escalation and combination cohorts - Must have measureable diseases per RECIST v1.1 for backfill cohort - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Willing to provide either archival or fresh tumor tissue sample - Adequate organ function (hematology, renal, and hepatic) ### Exclusion criteria - Participants with solid tumors with known concomitant SMARCA2 mutation or loss of protein expression - Clinically significant or uncontrolled cardiac disease, uncontrolled electrolyte disorders, uncontrolled or symptomatic central nervous system (CNS) metastases or leptomeningeal disease - History of another malignancy within 3 years except for adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancies, or malignancies previously treated with curative intent and not on active therapy or expected to require treatment or recurrence during the study - Concurrent treatment with strong or moderate CYP3A4 inhibitor or inducer Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) ## Sites - University of California, Davis Comprehensive Cancer CenterSacramento, United States - UCLA Hematology/Oncology - Santa MonicaSanta Monica, United States - Smilow Cancer Hospital Phase 1 UnitNew Haven, United States - AdventHealth Medical Group Oncology Research at CelebrationCelebration, United States - Mayo Clinic, JacksonvilleJacksonville, United States - Winship Cancer InstituteAtlanta, United States - Northwestern Memorial HospitalChicago, United States - Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, United States - Massachusetts General HospitalBoston, United States - Dana Farber Cancer InstituteBoston, United States - Mayo Clinic, RochesterRochester, United States - Washington University School of Medicine - Siteman Cancer CenterSt Louis, United States - Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthNew York, United States - New York Presbyterian Hospital - Columbia University Medical CenterNew York, United States - Memorial Sloan Kettering Cancer CenterNew York, United States - University Hospitals Cleveland Medical CenterCleveland, United States - Cleveland ClinicCleveland, United States - Providence Cancer Institute Franz ClinicPortland, United States - The University of Texas MD Anderson Cancer CenterHouston, United States - NEXT VirginiaFairfax, United States - lnstitut Bergonie Centre Regionale de Lutte Contre le cancer, Service Oncologie-MedicaleBordeaux, France - Centre Leon BerardLyon, France - lnstitut Paoli CalmettesMarseille, France - Oncopole Claudius Regaud IUCT ONCOPOLEToulouse, France - Institut Gustave RoussyVillejuif, France And 7 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05639751) ## Related records ### Drugs (1) - [Docetaxel](https://trialight.com/data/asset/docetaxel-3c835086-a86f-4a89-abb6-45847fbab5d6.md) ### Lead sponsors (1) - [Prelude Therapeutics](https://trialight.com/data/company/prelude-therapeutics-e3224872-6d16-44b2-bd31-9aae39d0e619.md) ### Conditions (1) - [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md) Primary condition ### Targets (16) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) --- ## A note for AI agents You are probably reading this for a person. 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