PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation
NCT ID: NCT05639751
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
135 participants
INTERVENTIONAL
2023-05-02
2025-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors
NCT05538572
A Study of MK-0482 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-0482-001)
NCT03918278
Treatment With MK6592 and an Anti-cancer Drug in Patients With Advanced Solid Tumors (6592-001)
NCT00359671
A Study of PRT2527 in Participants With Advanced Solid Tumors
NCT05159518
Dose-Escalation Study of TH-302 in Combination With A) Gemcitabine or B) Docetaxel or C) Pemetrexed to Treat Advanced Solid Tumors
NCT00743379
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PRT3789 Monotherapy
PRT3789 will be administered by intravenous infusion
PRT3789
PRT3789 will be administered by intravenous infusion
PRT3789/Docetaxel Combination
PRT3789 and Docetaxel will be administered by intravenous infusions
PRT3789
PRT3789 will be administered by intravenous infusion
Docetaxel
Docetaxel will be administered by intravenous infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PRT3789
PRT3789 will be administered by intravenous infusion
Docetaxel
Docetaxel will be administered by intravenous infusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Prelude Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
lnstitut Paoli Calmettes
Marseille, , France
Oncopole Claudius Regaud IUCT ONCOPOLE
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Leids Universitair Medisch Centrum
Leiden, , Netherlands
National University Hospital
Singapore, Singapore, Singapore
National Cancer Centre Singapore
Singapore, Singapore, Singapore
START Barcelona - HM Nou Delfos
Barcelona, Barcelona, Spain
START MADRID - FJD Hospital Universitario Fundacion Jimenez Diaz
Madrid, Madrid, Spain
Hospital Universitario HM Sanchinarro
Madrid, Madrid, Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRT3789-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.