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PRT3789 in Participants with Select Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation

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A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3789 in Participants with Select Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation

  • Sex at Birth: Any
  • Age: Adult (18 - 64), Older Adult (65+)
  • Accepting Healthy People: No
  • Type: Interventional / Therapeutic
  • Trial Phase: Phase I
  • Conditions Being Studied: Cancer - Solid Tumor

Study Purpose

This is a Phase 1 dose-escalation study of PRT3789, a SMARCA2 degrader, in participants with advanced or metastatic solid tumors with loss of SMARCA4 due to truncating mutation and/or deletion. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of PRT3789 monotherapy and in combination with docetaxel, describe any dose limiting toxicities (DLTs), define the dosing schedule, and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) to be used in subsequent development of PRT3789.

Principal Investigator
Afshin Dowlati MD
Department/Division
Cancer (Any Solid Tumor)

Locations

UH Seidman Cancer Center
11100 Euclid Avenue
Cleveland OH, 44106

  • UH IRB: STUDY20221599
  • StudyID: PLT1Y22
  • ClinicalTrials.gov: NCT05639751
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