TERMINATED

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

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Conditions

Advanced Solid TumorMetastatic Solid TumorNon-small Cell Lung CarcinomaSMARCA4 MutationEsophageal AdenocarcinomaEsophageal Squamous Cell CarcinomaGastric AdenocarcinomaGastric Squamous Cell CarcinomaGastroesophageal Junction AdenocarcinomaGastroesophageal Junction Squamous Cell CarcinomaAdvanced Solid TumorsBRG1BRMDegraderMetastatic Solid TumorsNon-Small Cell Lung CancersNSCLCPRT7732SMARCA2SMARCA4

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4

Quick Facts

Study Start:2024-11-04
Study Completion:2026-01-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06560645

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures
  2. * 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
  3. * Must have measurable or non-measurable (but evaluable) disease per RECIST v1.1
  4. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  5. * Willing to provide either archival or fresh tumor tissue sample
  6. * Adequate organ function (hematology, renal, and hepatic)
  1. * Participants with solid tumors with known concomitant SMARCA2 mutation or loss of protein expression
  2. * Clinically significant or uncontrolled cardiac disease, uncontrolled electrolyte disorders, uncontrolled or symptomatic central nervous system (CNS) metastases or leptomeningeal disease
  3. * 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
  4. * Receipt of any targeted therapy directed against BRM/BRG1 (SMARCA2/SMARCA4).

Contacts and Locations

Study Locations (Sites)

UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
United States
Brigitte Harris Cancer Pavilion
Detroit, Michigan, 48202
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065
United States
UNC Hospitals, The University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27514
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: Prelude Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-04
Study Completion Date2026-01-28

Study Record Updates

Study Start Date2024-11-04
Study Completion Date2026-01-28

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • 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