ENV-101 (taladegib) for Gorlin Syndrome

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Research Site, Zion, ILGorlin SyndromeENV-101 (taladegib) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it's effective and safe for people with cancer who have a specific mutation.

Eligible Conditions
  • Gorlin Syndrome

Treatment Effectiveness

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: through study completion, an average of 6 months

Month 6
Change in Gli1 inhibition
Change in steady-state exposure to study medication
Month 6
Clinical Benefit Rate (CBR)
Duration of Response (DOR)
Frequency of Adverse Events (AEs)
Frequency of unacceptable toxicities
ORR by Investigator
Objective Response Rate (ORR)
Overall Survival (OS)
Progression Free Survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

300 mg ENV-101
1 of 2
200 mg ENV-101
1 of 2

Experimental Treatment

44 Total Participants · 2 Treatment Groups

Primary Treatment: ENV-101 (taladegib) · No Placebo Group · Phase 2

300 mg ENV-101
Drug
Experimental Group · 1 Intervention: ENV-101 (taladegib) · Intervention Types: Drug
200 mg ENV-101
Drug
Experimental Group · 1 Intervention: ENV-101 (taladegib) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 6 months

Who is running the clinical trial?

Endeavor Biomedicines, Inc.Lead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
Srikanth Pendyala, M.D.Study DirectorEndeavor Biomedicines
1 Previous Clinical Trials
60 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to swallow pills or take medication by mouth.
You have tried all the usual treatments for your condition, and they haven't worked. Or, there are no established treatments for your condition, or you have chosen not to undergo them.
You are expected to live for at least 3 more months.

Frequently Asked Questions

Are investigators currently enrolling participants in this research?

"Affirmative. According to the information hosted on clinicaltrials.gov, this experiment is actively searching for potential participants and was initially posted on May 24th 2022. 44 individuals need to be enrolled from 18 different medical locations with November 28th being its most recent update." - Anonymous Online Contributor

Unverified Answer

What has been the Food and Drug Administration's stance on taladegib (ENV-101) thus far?

"Taladegib (ENV-101) has been assigned a safety rating of 2, as this Phase 2 trial has yielded some data on its security but not yet any proof of efficacy." - Anonymous Online Contributor

Unverified Answer

How many medical sites are administering this clinical trial?

"This medical experiment is presently enrolling patients from 18 different sites across the US, including Tampa, Madison and San Diego. To reduce difficulties associated with travel, it's suggested that participants select a clinic nearest to them." - Anonymous Online Contributor

Unverified Answer

How many individuals are being monitored as part of this scientific investigation?

"Affirmative. Clinicaltrials.gov documents show that since its announcement on May 24th 2022, this research study has been actively recruiting participants at 18 different sites and is still searching for 44 more volunteers to join the trial." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.