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A Phase 1 Study of PRT7732, an Oral SMARCA2 Degrader, in Patients with Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation

Basic Information

Recruitment status	Not Recruiting
Health condition(s) or Problem(s) studied	Advanced or Metastatic Solid Tumors with a SMARCA4 mutation
Date of first enrollment	12/06/2025
Target sample size	10
Countries of recruitment	Australia,Japan,Republic of Korea,Japan,Spain,Japan,Germany,Japan,United States,Japan
Study type	Interventional
Intervention(s)	-PRT7732 PRT7732 capsules will be self- administered once daily at the dose level assigned

Outcome(s)

Primary Outcome	-Dose Limiting toxicity (DLT) of PRT7732 -Safety and tolderability of PRT7732 as measured by incidence of DLTs -Safety and tolerability of PRT7732 as measured by incidence of laboratory deviations -Safety and tolerability as measured by rates of dose modification due to AEs according to NCI CTCAE -Maximum tolerated dose (MTD) of PRT7732 -Recommended dose for expansion (RDE) of PRT7732
Secondary Outcome	-Efficacy of PRT7732 -Pharmacokinetic profile of PRT7732 as a single agent: Maximum observed plasma concentration -Pharmacokinetic profile of PRT7732 as a single agent: Area under the curve -Pharmacokinetic profile of PRT7732 as a single agent: Time of maximum concentration (Tmax) and half-life (T1/2) -Pharmacodynamic effects of PRT7732 as a single agent

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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)
Exclude 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).