Spots Global Cancer Trial Database for A Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations
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Trial Identification
Brief Title: A Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations
Official Title: 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
Study ID: NCT05199584
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Los Angeles, California, United States
Research Site, Santa Rosa, California, United States
Research Site, Tampa, Florida, United States
Research Site, Zion, Illinois, United States
Research Site, Covington, Louisiana, United States
Research Site, Las Vegas, Nevada, United States
Research Site, New York, New York, United States
Research Site, Durham, North Carolina, United States
Research Site, Cincinnati, Ohio, United States
Research Site, Columbus, Ohio, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Nashville, Tennessee, United States
Research Site, Houston, Texas, United States
Research Site, Fredericksburg, Virginia, United States
Research Site, Lynchburg, Virginia, United States
Research Site, Madison, Wisconsin, United States
Contact Details
Name: Paul Frohna, M.D., Ph.D.
Affiliation: Endeavor Biomedicines
Role: STUDY_DIRECTOR
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