PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation

Completed · Phase 1

Conditions studied: Advanced Solid Tumor, Metastatic Solid Tumor, Non-small Cell Lung Cancers, SMARCA4 Gene Mutation

In brief

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.

Key facts

Study ID

NCT05639751

Run by

Prelude Therapeutics

People needed

135

Starts

2023-05-02

Expected to finish

2025-10-01

Last updated by the study team

2025-10-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• lnstitut Paoli Calmettes — Marseille, France
• University of California, Davis Comprehensive Cancer Center — Sacramento, California, United States
• UCLA Hematology/Oncology - Santa Monica — Santa Monica, California, United States
• Smilow Cancer Hospital Phase 1 Unit — New Haven, Connecticut, United States
• AdventHealth Medical Group Oncology Research at Celebration — Celebration, Florida, United States
• Mayo Clinic, Jacksonville — Jacksonville, Florida, United States
• Winship Cancer Institute — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Mayo Clinic, Rochester — Rochester, Minnesota, United States
• Washington University School of Medicine - Siteman Cancer Center — St Louis, Missouri, United States
• Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States
• New York Presbyterian Hospital - Columbia University Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Providence Cancer Institute Franz Clinic — Portland, Oregon, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• NEXT Virginia — Fairfax, Virginia, United States
• lnstitut Bergonie Centre Regionale de Lutte Contre le cancer, Service Oncologie-Medicale — Bordeaux, France
• Centre Leon Berard — Lyon, France
• Oncopole Claudius Regaud IUCT ONCOPOLE — Toulouse, France
• Institut Gustave Roussy — Villejuif, France

Full record on ClinicalTrials.gov

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