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NCT05639751CompletedPhase 1

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

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 · Last updated 16 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
135 (actual)
First submitted
11 Nov 2022
Start date
2 May 2023
Primary completion date
1 Oct 2025
Lead sponsor
Prelude Therapeutics Incorporated
NCT number
NCT05639751
EU CT number
2022-502850-14-00

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 135
  • From 2 May 2023 to the primary completion date, 1 Oct 2025
  • 33 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants with solid tumors with known concomitant SMARCA2 mutation or loss of protein expression
  • Concurrent treatment with strong or moderate CYP3A4 inhibitor or inducer

Other illness

  • 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

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (33)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Technische Universitaet Dresden
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DresdenGermanyCompleted
Hospital HM Nou Delfos
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BarcelonaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainCompleted
Hospital Universitario HM Sanchinarro
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MadridSpainCompleted
Institut Bergonie
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BordeauxFranceCompleted
Centre Leon Berard
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LyonFranceCompleted
Institut Paoli-Calmettes
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MarseilleFranceCompleted
Oncopole Claudius Regaud
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ToulouseFranceCompleted
Institut Gustave Roussy
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VillejuifFranceCompleted
Leiden University Medical Center
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LeidenNetherlandsCompleted
National Cancer Centre Singapore
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SingaporeSingaporeUnknown status
National University Hospital
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SingaporeSingaporeUnknown status
Winship Cancer Institute
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AtlantaUnited StatesUnknown status
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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BaltimoreUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
AdventHealth Medical Group Oncology Research at Celebration
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CelebrationUnited StatesUnknown status
Northwestern Memorial Hospital
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ChicagoUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
University Hospitals Cleveland Medical Center*
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ClevelandUnited StatesUnknown status
NEXT Virginia
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FairfaxUnited StatesUnknown status
The University of Texas MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Mayo Clinic- Jacksonville
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JacksonvilleUnited StatesUnknown status
Smilow Cancer Hospital Phase 1 Unit
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New HavenUnited StatesUnknown status
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
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New YorkUnited StatesUnknown status
New York Presbyterian Hospital-Columbia University Medical Center
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New YorkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Providence Cancer Institute Franz Clinic
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PortlandUnited StatesUnknown status
Mayo Clinic - Rochester
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RochesterUnited StatesUnknown status
University of California Davis Comprehensive Cancer Center
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SacramentoUnited StatesUnknown status
UCLA Hematology-Oncology - Santa Monica
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Santa MonicaUnited StatesUnknown status
Washington University School of Medicine - Siteman Cancer Center
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St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.