drugset / Trial / NCT05639751

PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation

NCT05639751 ↗

Phase 1 Completed 135 enrolled Prelude Therapeutics
Non-randomizedSequentialOpen-labelTreatment

Summary

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.

Timeline

Start
2023-05-02
Primary completion
2025-10-01
Completion
2025-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject PRT3789 Other / unclassified — Intravenous
Background Docetaxel Small molecule — Intravenous