A Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations
Public ClinicalTrials.gov record NCT05199584. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05199584
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 20 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 24, 2022 (Actual)
- Primary completion
- Feb 20, 2024 (Actual)
- Completion
- Feb 20, 2024 (Actual)
- Last update posted
- Mar 5, 2026
2022 – 2024
United States locations
- U.S. sites
- 16
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Los Angeles | California | 90095 | — |
| Research Site | Santa Rosa | California | 95403 | — |
| Research Site | Tampa | Florida | 33609 | — |
| Research Site | Zion | Illinois | 60099 | — |
| Research Site | Covington | Louisiana | 70433 | — |
| Research Site | Las Vegas | Nevada | 89102 | — |
| Research Site | New York | New York | 10065 | — |
| Research Site | Durham | North Carolina | 27710 | — |
| Research Site | Cincinnati | Ohio | 45229 | — |
| Research Site | Columbus | Ohio | 43210 | — |
| Research Site | Pittsburgh | Pennsylvania | 15232 | — |
| Research Site | Nashville | Tennessee | 37203 | — |
| Research Site | Houston | Texas | 77030 | — |
| Research Site | Fredericksburg | Virginia | 22408 | — |
| Research Site | Lynchburg | Virginia | 24501 | — |
| Research Site | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05199584, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 5, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05199584 live on ClinicalTrials.gov.