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

Launched by PRELUDE THERAPEUTICS · Aug 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new oral medication called PRT7732, which is designed to target a specific mutation (called SMARCA4) found in certain advanced or metastatic solid tumors, including non-small cell lung cancer. The main goal of this study is to find out if PRT7732 is safe to use, how the body processes it, and whether it shows any signs of effectiveness in treating these types of cancer.

To participate in this study, patients should have a confirmed diagnosis of an advanced solid tumor that has either worsened despite standard treatments or for which standard treatments are not an option. Participants should also be able to attend all scheduled visits and provide a tissue sample for testing. The trial is open to individuals aged 65 and older, regardless of gender. During the study, participants will be closely monitored for any side effects and will receive guidance on how to manage their condition. It's important to note that patients with certain health issues or other specific genetic mutations may not be eligible for this trial.

Gender

ALL

Eligibility criteria

• 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 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).