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

Stopped early · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT06560645

Run by

Prelude Therapeutics

People needed

42

Starts

2024-11-04

Expected to finish

2026-01-28

Last updated by the study team

2026-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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