Testing PRT7732 for advanced solid tumors with a SMARCA4 mutation

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

This study is testing a new oral medication called PRT7732 to see if it helps people with advanced solid tumors that have a specific genetic mutation called SMARCA4.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Prelude Therapeutics (industry)
• Locations: 22 sites (San Francisco, California and 21 other locations)
• Trial ID: NCT06560645 on ClinicalTrials.gov

What this trial studies

This Phase 1 study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PRT7732, an oral SMARCA2 degrader, in patients with advanced or metastatic solid tumors harboring a SMARCA4 mutation. The study is open-label and multi-center, aiming to enroll approximately 104 participants. Patients will be monitored for their response to the treatment and any side effects experienced during the trial.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced, recurrent, or metastatic solid tumors that have a confirmed SMARCA4 mutation and have either progressed on or are ineligible for standard therapies.

Not a fit: Patients with solid tumors that have a known concomitant SMARCA2 mutation or significant uncontrolled health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have limited treatment alternatives.

How similar studies have performed: While this approach is novel in targeting SMARCA4 mutations specifically, similar studies targeting other mutations have shown promising results.

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).

Where this trial is running

San Francisco, California and 21 other locations

• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States (RECRUITING)
• Brigitte Harris Cancer Pavilion — Detroit, Michigan, United States (RECRUITING)
• Memorial Sloan Kettering Cancer Center - Main Campus — New York, New York, United States (RECRUITING)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (RECRUITING)
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
• SCRI Oncology Partners — Nashville, Tennessee, United States (RECRUITING)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
• University of Virginia Comprehensive Cancer Center — Charlottesville, Virginia, United States (RECRUITING)
• Southern Highlands Cancer Centre — Bowral, New South Wales, Australia (RECRUITING)
• Scientia Clinical Research Ltd — Randwick, New South Wales, Australia (RECRUITING)
• Monash Health — Clayton, Victoria, Australia (RECRUITING)
• Linear Clinical Research Ltd — Nedlands, Western Australia, Australia (RECRUITING)
• University Clinic Cologne, Clinic for Internal Medicine — Cologne, North Rhine-Westfalia, Germany (RECRUITING)
• Technische Universitat Dresden, Medizinlsche Fakultat Carl Gustav Carus Nationales Centrum fur Tumorerkrankungen Dresden, Early Clinical Trial Unit (NCT/UCC ECTU) — Dresden, Saxony, Germany (RECRUITING)
• National Cancer Center Hospital — Chuo Ku, Tokyo, Japan (RECRUITING)
• Cancer Institute Hospital of JFCR — Koto-ku, Tokyo, Japan (RECRUITING)
• National Cancer Center — Goyang-Si, Gyeonggi-do, Korea, Republic of (RECRUITING)
• Severance Hospital, Yonsei University Health System — Seoul, Korea, Republic of (RECRUITING)
• Samsung Medical Center — Seoul, Korea, Republic of (RECRUITING)
• Hospital Universitario Vall d'Hebron — Barcelona, Spain (RECRUITING)
• Start Madrid-FJD, Hospital Universitario Fundacion Jimenez Diaz-Servicio de Oncologia — Madrid, Spain (RECRUITING)
• Hospital Universitario HM Sanchinarro — Madrid, Spain (RECRUITING)

Study contacts

• Study coordinator: Study Contact (Please Do Not Disclose Personal Information)

Conditions: Advanced Solid Tumor, Metastatic Solid Tumor, Non-small Cell Lung Carcinoma, SMARCA4 Mutation, Advanced Solid Tumors, BRG1, BRM, Degrader