PRT3789 treatment for advanced solid tumors with SMARCA4 mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 dose-escalation study evaluates PRT3789, a SMARCA2 degrader, in patients with advanced or metastatic solid tumors that have a loss of SMARCA4 due to mutations or deletions. The study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRT3789 both as a standalone treatment and in combination with docetaxel. Participants will be enrolled in various cohorts to determine the maximum tolerated dose and recommended phase 2 dose for future studies. Approximately 186 participants will be included in this open-label, multi-center trial.

Why it matters

Who can join: the full rules

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 (dose escalation and combination cohorts) and loss of function mutation of SMARCA4 (backfill cohorts) by local testing that have either progress on or ineligible for standard of care therapy
* Must have measurable or non-measureable (but evaluable) disease per RECIST v1.1 for dose escalation and combination cohorts
* Must have measureable diseases per RECIST v1.1 for backfill cohort
* 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 noninvasive 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
* Concurrent treatment with strong or moderate CYP3A4 inhibitor or inducer

Where it's running

• University of California, Davis Comprehensive Cancer Center
  Sacramento, California, United States Recruiting
• UCLA Hematology/Oncology - Santa Monica
  Santa Monica, California, United States Recruiting
• Smilow Cancer Hospital Phase 1 Unit
  New Haven, Connecticut, United States Recruiting
• AdventHealth Medical Group Oncology Research at Celebration
  Celebration, Florida, United States Recruiting
• Mayo Clinic, Jacksonville
  Jacksonville, Florida, United States Recruiting
• Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting

Study contacts

• Study coordinator: Study Contact (Please Do Not Disclose Personal Information)
• Email: clinicaltrials@preludetx.com
• Phone: See Email

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.