NCT05639751

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Prelude Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label, multi-center, dose-escalation, first in human, Phase 1 study of PRT3789 as monotherapy and in combination with docetaxel, a SMARCA2 degrader, evaluating participants with advanced or metastatic solid tumors with loss of SMARCA4 due to truncating mutation and/or deletion. The study will evaluate escalating doses of PRT3789 until the MTD or RP2D is determined. Taking into account pharmacokinetic and pharmacodynamic data from the preceding dose levels, the dose may be escalated until a dose limiting toxicity is identified. Approximately 186 participants will be enrolled in monotherapy, dose escalation, backfill, and combination cohorts.

Conditions

• Advanced Solid Tumor
• Metastatic Solid Tumor
• Non-small Cell Lung Cancers
• SMARCA4 Gene Mutation

Interventions

Type	Name	Description
DRUG	PRT3789	PRT3789 will be administered by intravenous infusion
DRUG	Docetaxel	Docetaxel will be administered by intravenous infusion

Timeline

• Start date: 2023-05-02
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2022-12-06
• Last updated: 2025-10-16

Locations

32 sites across 5 countries: United States, France, Netherlands, Singapore, Spain

Regulatory

• FDA-regulated drug study