Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

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.

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

Details

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.

Keywords

Advanced Solid Tumor, Metastatic Solid Tumor, Non-small Cell Lung Carcinoma, SMARCA4 Mutation, Advanced Solid Tumors, BRG1, BRM, Degrader, Metastatic Solid Tumors, Non-Small Cell Lung Cancers, NSCLC, PRT7732, SMARCA2, SMARCA4, Neoplasms, Non-Small-Cell Lung Carcinoma

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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 another malignancy within 3 years except for adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, 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).

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center not yet accepting patients
    San Francisco California 94158 United States
  • The University of Texas MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States
  • University Hospitals Cleveland Medical Center accepting new patients
    Cleveland Ohio 44106 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Prelude Therapeutics
ID
NCT06560645
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 104 study participants
Last Updated