NCT06560645

A Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation

A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Prelude Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PRT7732 in patients with select advanced or metastatic solid tumors with a SMARCA4 mutation.

Detailed description

This is an open-label, multi-center, first-in-human, Phase 1 study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PRT7732 an oral SMARCA degrader in patients with select advanced or metastatic solid tumors with a SMARCA4 mutation. Approximately 104 participants will be enrolled.

Conditions

• Advanced Solid Tumor
• Metastatic Solid Tumor
• Non-small Cell Lung Carcinoma
• SMARCA4 Mutation
• Esophageal Adenocarcinoma
• Esophageal Squamous Cell Carcinoma
• Gastric Adenocarcinoma
• Gastric Squamous Cell Carcinoma
• Gastroesophageal Junction Adenocarcinoma
• Gastroesophageal Junction Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	PRT7732	PRT7732 capsules will be self-administered once daily at the dose-level assigned

Timeline

• Start date: 2024-11-04
• Primary completion: 2026-01-28
• Completion: 2026-01-28
• First posted: 2024-08-19
• Last updated: 2026-02-02

Locations

28 sites across 6 countries: United States, Australia, Germany, Japan, South Korea, Spain

Regulatory

• FDA-regulated drug study