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

Last updated: June 2, 2025
Sponsor: Prelude Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Non-small Cell Lung Cancer

Neoplasms

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 another malignancy within 3 years except for adequately treated basalcell or squamous cell skin cancer, superficial bladder cancer, prostateintraepithelial neoplasm, carcinoma in situ of the cervix, or other non-invasive orindolent malignancies, or malignancies previously treated with curative intent andnot on active therapy or expected to require treatment or recurrence during thestudy

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

Study Design

Total Participants: 104
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

    Active - Recruiting

  • Southern Highlands Cancer Centre

    Bowral, New South Wales 2576
    Australia

    Active - Recruiting

  • Scientia Clinical Research Ltd

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Linear Clinical Research Ltd

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • University Clinic Cologne, Clinic for Internal Medicine

    Cologne, North Rhine-Westfalia 50937
    Germany

    Active - Recruiting

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

    Dresden, Saxony 01307
    Germany

    Active - Recruiting

  • National Cancer Center Hospital

    Chuo Ku, Tokyo 104-0045
    Japan

    Active - Recruiting

  • Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo 135-8550
    Japan

    Active - Recruiting

  • National Cancer Center

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

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Active - Recruiting

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

    Madrid, 28040
    Spain

    Active - Recruiting

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California 94158
    United States

    Active - Recruiting

  • University of Kansas Cancer Center

    Westwood, Kansas 46214
    United States

    Site Not Available

  • Brigitte Harris Cancer Pavilion

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center - Main Campus

    New York, New York 10065
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

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