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PRT3789 treatment for advanced solid tumors with SMARCA4 mutations

A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3789 as Monotherapy and in Combination With Docetaxel in Participants With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation

Phase 1 Interventional Prelude Therapeutics · NCT05639751

This study is testing a new treatment called PRT3789 for people with advanced solid tumors that have specific genetic changes to see if it is safe and effective, both on its own and with another drug.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment226 (estimated)
Ages18 Years and up
SexAll
SponsorPrelude Therapeutics Industry-sponsored
Locations32 sites (Sacramento, California and 31 other locations)
Trial IDNCT05639751 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced 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 known concomitant SMARCA2 mutations 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 harboring SMARCA4 mutations.

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

Eligibility criteria

Show full inclusion / exclusion 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 (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 this trial is running

Sacramento, California and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid TumorMetastatic Solid TumorNon-small Cell Lung CancersSMARCA4 Gene MutationAdvanced Solid TumorsBRG1BRMMetastatic Solid Tumors
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.