A Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation

Last updated: November 11, 2025
Sponsor: Prelude Therapeutics
Overall Status: Active - Not Recruiting

Phase

1

Condition

Esophageal Disorders

Neoplasm Metastasis

Adenocarcinoma

Treatment

PRT7732

Clinical Study ID

NCT06560645
PRT7732-01
  • Ages > 18
  • All Genders

Study Summary

This is a Phase 1 study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PRT7732 in patients with select advanced or metastatic solid tumors with a SMARCA4 mutation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Willing and able to comply with all scheduled visits, treatment plan, laboratorytests, lifestyle considerations (including contraception requirements), and otherstudy procedures

  • Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancywith any mutation of SMARCA4 by local testing that has either progressed on or isineligible 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

Exclusion Criteria:

  • Participants with solid tumors with known concomitant SMARCA2 mutation or loss ofprotein expression

  • Clinically significant or uncontrolled cardiac disease, uncontrolled electrolytedisorders, uncontrolled or symptomatic central nervous system (CNS) metastases orleptomeningeal disease

  • History of other malignancy within 3 years except for adequately treated basal cellor squamous cell skin cancer, superficial bladder cancer, prostate intraepithelialneoplasm, prostate adenocarcinoma with Gleason score of 3+3 or less, carcinoma insitu of the cervix, or other non-invasive or indolent malignancies, or malignanciespreviously treated with curative intent and not on active therapy or expected torequire treatment or recurrence during the study

  • Receipt of any targeted therapy directed against BRM/BRG1 (SMARCA2/SMARCA4).

Study Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: PRT7732
Phase: 1
Study Start date:
November 04, 2024
Estimated Completion Date:
April 30, 2027

Study Description

This is an open-label, multi-center, first-in-human, Phase 1 study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PRT7732 an oral SMARCA degrader in patients with select advanced or metastatic solid tumors with a SMARCA4 mutation. Approximately 104 participants will be enrolled.

Connect with a study center

  • Border Medical Oncology Research Unit

    Albury, New South Wales 2640
    Australia

    Site Not Available

  • Southern Highlands Cancer Centre

    Bowral, New South Wales 2576
    Australia

    Site Not Available

  • Scientia Clinical Research Ltd

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Border Medical Oncology Research Unit

    Albury 2178174, New South Wales 2155400 2640
    Australia

    Site Not Available

  • Southern Highlands Cancer Centre

    Bowral 2174400, New South Wales 2155400 2576
    Australia

    Site Not Available

  • Scientia Clinical Research Ltd

    Randwick 2208285, New South Wales 2155400 2031
    Australia

    Site Not Available

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Monash Health

    Clayton 2171400, Victoria 2145234 3168
    Australia

    Site Not Available

  • Linear Clinical Research Ltd

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Linear Clinical Research Ltd

    Nedlands 2064874, Western Australia 2058645 6009
    Australia

    Site Not Available

  • University Clinic Cologne, Clinic for Internal Medicine

    Cologne, North Rhine-Westfalia 50937
    Germany

    Site Not Available

  • University Clinic Cologne, Clinic for Internal Medicine

    Cologne 2886242, North Rhine-Westfalia 50937
    Germany

    Site Not Available

  • Technische Universitat Dresden, Medizinlsche Fakultat Carl Gustav Carus Nationales Centrum fur Tumorerkrankungen Dresden, Early Clinical Trial Unit (NCT/UCC ECTU)

    Dresden, Saxony 01307
    Germany

    Site Not Available

  • Technische Universitat Dresden, Medizinlsche Fakultat Carl Gustav Carus Nationales Centrum fur Tumorerkrankungen Dresden, Early Clinical Trial Unit (NCT/UCC ECTU)

    Dresden 2935022, Saxony 2842566 01307
    Germany

    Site Not Available

  • Kindai University Hospital

    Osakasayama, Osaka 589-8511
    Japan

    Site Not Available

  • The Univerity of Osaka Hospital

    Suita, Osaka 565-0871
    Japan

    Site Not Available

  • Kindai University Hospital

    Sayama 6825499, Osaka 1853904 589-8511
    Japan

    Site Not Available

  • The Univerity of Osaka Hospital

    Suita 1851483, Osaka 1853904 565-0871
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo Ku, Tokyo 1850144 104-0045
    Japan

    Site Not Available

  • Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo 1850144 135-8550
    Japan

    Site Not Available

  • National Cancer Center

    Goyang-Si, Gyeonggi-do 10408
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • National Cancer Center

    Goyang-si 1842485, Gyeonggi-do 1841610 10408
    South Korea

    Site Not Available

  • Samsung Medical Center

    Seoul 1835848, 06351
    South Korea

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul 1835848, 03722
    South Korea

    Site Not Available

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Site Not Available

  • Start Madrid-FJD, Hospital Universitario Fundacion Jimenez Diaz-Servicio de Oncologia

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid 3117735, 28050
    Spain

    Site Not Available

  • Start Madrid-FJD, Hospital Universitario Fundacion Jimenez Diaz-Servicio de Oncologia

    Madrid 3117735, 28040
    Spain

    Site Not Available

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California 94158
    United States

    Site Not Available

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco 5391959, California 5332921 94158
    United States

    Site Not Available

  • University of Kansas Cancer Center

    Westwood, Kansas 46214
    United States

    Site Not Available

  • Brigitte Harris Cancer Pavilion

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Brigitte Harris Cancer Pavilion

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center - Main Campus

    New York, New York 10065
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center - Main Campus

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

  • UNC Hospitals, The University of North Carolina Chapel Hill

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • UNC Hospitals, The University of North Carolina Chapel Hill

    Chapel Hill 4460162, North Carolina 4482348 27514
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • University of Virginia Comprehensive Cancer Center

    Charlottesville 4752031, Virginia 6254928 22903
    United States

    Site Not Available

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