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

NCT05199584 ↗

Phase 2 Completed 20 enrolled Endeavor Biomedicines, Inc.

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2022-05-24
Primary completion: 2024-02-20
Completion: 2024-02-20

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	taladegib	Small molecule	200 mg	—
Subject	taladegib	Small molecule	300 mg	—

Indications

No indication recorded.