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Hedgehog Pathway Inhibitor
Taladegib for Advanced Cancer
Phase 2
Waitlist Available
Research Sponsored by Endeavor Biomedicines, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has histologically or cytologically confirmed solid tumor that harbors a PTCH1 loss of function mutation, identified via genomic sequencing routinely performed at a CLIA certified laboratory
Able to take medication orally
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 months
Awards & highlights
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.
Who is the study for?
Adults with advanced solid tumors that have a specific genetic change (PTCH1 loss of function mutation) can join this trial. They must be able to take pills, have a life expectancy over 3 months, and not respond to standard treatments or refuse them. People who are pregnant, nursing, or unwilling to use birth control; those with severe allergies to ENV-101 components; active infections like HIV/HBV/HCV; serious heart conditions; recent major surgeries; other cancers within the last 5 years; or uncontrolled autoimmune diseases cannot participate.Check my eligibility
What is being tested?
The trial is testing ENV-101 (taladegib), which blocks a cancer growth pathway in patients whose tumors no longer respond to usual treatments. It's done in two stages: first, finding the right dose by trying two different amounts on about 44 people. Then possibly expanding the group based on these results.See study design
What are the potential side effects?
Possible side effects of taladegib may include digestive issues due to its oral intake nature, allergic reactions for those sensitive to its ingredients, and potential impacts on liver function as it interacts with certain enzymes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor has a PTCH1 mutation, confirmed by a certified lab test.
Select...
I can take medicine by mouth.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Change in Gli1 inhibition
Change in steady-state exposure to study medication
Clinical Benefit Rate (CBR)
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: 300 mg ENV-101Experimental Treatment1 Intervention
ENV-101 (taladegib) tablets, 300 mg once-daily in 28-day cycles
Group II: 200 mg ENV-101Experimental Treatment1 Intervention
ENV-101 (taladegib) tablets, 200 mg once-daily in 28-day cycles
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Who is running the clinical trial?
Endeavor Biomedicines, Inc.Lead Sponsor
3 Previous Clinical Trials
382 Total Patients Enrolled
Paul Frohna, M.D., Ph.D.Study DirectorEndeavor Biomedicines
2 Previous Clinical Trials
62 Total Patients Enrolled
Srikanth Pendyala, M.D.Study DirectorEndeavor Biomedicines
2 Previous Clinical Trials
62 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't needed strong medication for an autoimmune disease in the last 2 years, except for thyroid issues.I agree not to donate blood during and for 30 days after the study.You have had a serious allergic reaction or severe allergic response to any part of ENV-101.I do not have serious heart problems or my condition is stable and well-managed.I haven't been part of any clinical study or taken experimental drugs in the last 28 days.I haven't had any cancer other than my current type in the last 5 years, except for minor skin cancers or very early-stage cancers that were fully treated.I haven't had major surgery in the last 28 days and don't expect to need one during the study.I am willing to use birth control during the study and for 3 months after.I am not pregnant or nursing.My tumor has a PTCH1 mutation, confirmed by a certified lab test.I don't have lasting side effects from previous treatments, except for anemia, hair loss, skin color changes, nerve damage from platinum drugs, or stable hormone issues.I can take medicine by mouth.I don't have severe nausea, vomiting, malabsorption issues, or significant bowel surgery that would affect medication absorption.I am at least 18 years old, or if under 18, my bone age is mature enough.I haven't taken strong medication that affects liver enzymes in the last 12 days.I do not have an active infection or confirmed HIV, HBV, or HCV at the start of the study.I am not currently receiving any cancer treatments other than what this study provides.I have fluid buildup needing frequent draining but can have a catheter.I agree not to donate sperm/eggs during and for 3 months after the study.I have tried all standard treatments without success, or I have chosen not to undergo standard treatments.
Research Study Groups:
This trial has the following groups:- Group 1: 300 mg ENV-101
- Group 2: 200 mg ENV-101
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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