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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Advanced Solid Tumor Metastatic Solid Tumor Non-small Cell Lung Carcinoma SMARCA4 Mutation Esophageal Adenocarcinoma Esophageal Squamous Cell Carcinoma Gastric Adenocarcinoma Gastric Squamous Cell Carcinoma Gastroesophageal Junction Adenocarcinoma Gastroesophageal Junction Squamous Cell Carcinoma

Keywords

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Advanced Solid Tumors BRG1 BRM Degrader Metastatic Solid Tumors Non-Small Cell Lung Cancers NSCLC PRT7732 SMARCA2 SMARCA4 Esophageal Adenocarcinoma Esophageal Squamous Cell Carcinoma Gastric Adenocarcinoma Gastric Squamous Cell Carcinoma Gastroesophageal Junction Adenocarcinoma Gastroesophageal Junction Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

PRT7732

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 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

* Participants with solid tumors with known concomitant SMARCA2 mutation or loss of protein expression
* 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prelude Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Site Status

Brigitte Harris Cancer Pavilion

Detroit, Michigan, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, United States

Site Status

UNC Hospitals, The University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

SCRI Oncology Partners

Nashville, Tennessee, United States

Site Status

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, United States

Site Status

Border Medical Oncology Research Unit

Albury, New South Wales, Australia

Site Status

Southern Highlands Cancer Centre

Bowral, New South Wales, Australia

Site Status

Scientia Clinical Research Ltd

Randwick, New South Wales, Australia

Site Status

Monash Health

Clayton, Victoria, Australia

Site Status

Linear Clinical Research Ltd

Nedlands, Western Australia, Australia

Site Status

University Clinic Cologne, Clinic for Internal Medicine

Cologne, North Rhine-Westfalia, Germany

Site Status

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

Dresden, Saxony, Germany

Site Status

Kindai University Hospital

Sayama, Osaka, Japan

Site Status

The Univerity of Osaka Hospital

Suita, Osaka, Japan

Site Status

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan

Site Status

Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

Site Status

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Site Status

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

Madrid, , Spain

Site Status

Hospital Universitario HM Sanchinarro

Madrid, , Spain

Site Status

Countries

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United States Australia Germany Japan South Korea Spain

Other Identifiers

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PRT7732-01

Identifier Type: -

Identifier Source: org_study_id