NCT05199584

A Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations

A Phase 2, Multi-Center Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Endeavor Biomedicines, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study employs a 2-stage design that aims to evaluate the efficacy and safety of ENV- 101, a potent Hedgehog (Hh) pathway inhibitor, in patients with refractory advanced solid tumors characterized by loss of function (LOF) mutations in the Patched-1 (PTCH1) gene. Stage 1 of this study will enroll approximately 44 patients randomized between two dose levels. As appropriate, Stage 2 of the study will expand enrollment based on the results of Stage 1.

Conditions

• Solid Tumors With PTCH1 Loss-of-function Mutations

Interventions

Type	Name	Description
DRUG	ENV-101 (taladegib)	tablets dosed once-daily

Timeline

• Start date: 2022-05-24
• Primary completion: 2024-02-20
• Completion: 2024-02-20
• First posted: 2022-01-20
• Last updated: 2026-03-05

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study