A Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation
NCT ID: NCT06560645
Last Updated: 2025-11-13
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
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ACTIVE_NOT_RECRUITING
PHASE1
42 participants
INTERVENTIONAL
2024-11-04
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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PRT7732
PRT7732 is administered as an oral capsule once daily. Dose escalation/de-escalation decisions will be guided by the BLRM method until the RDE is determined.
PRT7732
PRT7732 capsules will be self-administered once daily at the dose-level assigned
Interventions
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PRT7732
PRT7732 capsules will be self-administered once daily at the dose-level assigned
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy with any mutation of SMARCA4 by local testing that has either progressed on or is ineligible for standard of care therapy
* Must have measurable or non-measurable (but evaluable) disease per RECIST v1.1
* 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 other malignancy within 3 years except for adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, prostate adenocarcinoma with Gleason score of 3+3 or less, carcinoma in situ of the cervix, or other non-invasive 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
* Receipt of any targeted therapy directed against BRM/BRG1 (SMARCA2/SMARCA4).
18 Years
ALL
No
Sponsors
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Prelude Therapeutics
INDUSTRY
Responsible Party
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Locations
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UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Brigitte Harris Cancer Pavilion
Detroit, Michigan, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, United States
UNC Hospitals, The University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States
Border Medical Oncology Research Unit
Albury, New South Wales, Australia
Southern Highlands Cancer Centre
Bowral, New South Wales, Australia
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia
University Clinic Cologne, Clinic for Internal Medicine
Cologne, North Rhine-Westfalia, Germany
Technische Universitat Dresden, Medizinlsche Fakultat Carl Gustav Carus Nationales Centrum fur Tumorerkrankungen Dresden, Early Clinical Trial Unit (NCT/UCC ECTU)
Dresden, Saxony, Germany
Kindai University Hospital
Sayama, Osaka, Japan
The Univerity of Osaka Hospital
Suita, Osaka, Japan
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Start Madrid-FJD, Hospital Universitario Fundacion Jimenez Diaz-Servicio de Oncologia
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
Countries
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Other Identifiers
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PRT7732-01
Identifier Type: -
Identifier Source: org_study_id