UPCC 23924 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 Mutation

Investigating the Safety and Efficacy of an Investigational Oral Treatment for Advanced Solid Tumors with a Specific Genetic Mutation

Enrolling By Invitation
18 years or above
All
Phase 1
42 participants needed
1 Location

Brief description of study

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.

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: 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
  • Age: 18 years or above
  • Gender: All

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 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
  • Receipt of any targeted therapy directed against BRM/BRG1 (SMARCA2/SMARCA4).

This study investigates the safety and effectiveness of an investigational oral medication designed to degrade SMARCA2 in patients with advanced or metastatic solid tumors that have a SMARCA4 mutation. The purpose of this study is to understand how the investigational medication affects the body, how it is processed by the body, and whether it can potentially benefit patients with these specific types of tumors.

Participants in the study will receive the investigational medication and will undergo various procedures to assess their health and the medication's effects. These procedures may include regular health check-ups, laboratory tests, and imaging studies to monitor the tumor's response to the treatment.

  • Who can participate: Adults with advanced or metastatic solid tumors that have a SMARCA4 mutation can participate, provided they have an ECOG performance status of 0 or 1 and adequate organ function. Participants must be willing to comply with study procedures and provide a tumor tissue sample.
  • Study details: Participants will take an investigational oral medication and undergo various health assessments.
Updated on 02 Feb 2026. Study ID: 24-2075
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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