Clinical trialNCT05199584CompletedPhase 2Interventional

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

SponsorEndeavor Biomedicines, Inc.Enrollment20Solid Tumors With PTCH1 Loss-of-function Mutations

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Lisa Lancaster, M.D.
Endeavor Biomedicines
Study DirectorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

16 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Research Site
Los Angeles, California, United States
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Santa Rosa, California, United States
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Tampa, Florida, United States
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Zion, Illinois, United States
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Covington, Louisiana, United States
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Las Vegas, Nevada, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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Fredericksburg, Virginia, United States
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Lynchburg, Virginia, United States
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Madison, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ENV-101

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 24 May 2022
Primary completion: 20 Feb 2024
Completion: 20 Feb 2024
Last update posted: 5 Mar 2026
Registered enrollment: 20
Registry id: NCT05199584

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.