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A Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation
Trial Status: active
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.
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).
Additional locations may be listed on ClinicalTrials.gov for NCT06560645.