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Study Summary
This trial is testing a new drug to see if it's safe and effective against solid tumors. The study will first test increasing doses of the drug to see what effects it has, then expand to a larger group of people.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am willing to provide tissue samples from my tumor for the study.There are four groups of subjects that will be enrolled:
1. People with a confirmed type of cancer called malignant pleural mesothelioma and a specific genetic deficiency called NF2.
2. People with other types of solid tumors that also have the NF2 genetic deficiency.
3. People with a specific type of cancer called epithelioid hemangioendothelioma (EHE) and a specific gene fusion called TAZ-CAMTA1 or YAP1-TFE3.
4. People with any type of solid tumor that has a specific gene fusion called YAP1/TAZ.
People in all groups must have evidence of disease progression from prior treatment or active disease with cancer-related pain requiring strong pain medication. They must also have disease that can be measured or evaluated using specific criteria. Lastly, they must follow the study plan and agree to planned biopsy procedures.I am not pregnant or breastfeeding.I have a serious heart condition as described in the study details.I have advanced cancer with no standard treatment options left.I do not have untreated brain tumors or cancer that has spread to my brain.I cannot swallow or keep down oral medication.I am 18 years old or older.I do not have any severe illnesses that are not under control.
- Group 1: Experimental: IK-930 Single Agent Dose Escalation
- Group 2: Experimental: IK-930 Single Agent Dose Expansion
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Could you provide the quantity of facilities hosting this experimental program?
"At present, this clinical research is being conducted in 6 distinct medical centres. These are located in Grand Rapids, Nashville and Philadelphia amongst other cities. To reduce the burden of travel for participants it is important to select the site closest to you."
What is the upper limit for participants in this experiment?
"Affirmative. According to information hosted on clinicaltrials.gov, this medical study - which was first published on July 1st 2022 - is actively recruiting participants. 158 individuals from 6 different healthcare facilities need to be enrolled in the trial."
Has the FDA greenlit IK-930 for commercial release?
"As it is only a Phase 1 trial, the team at Power gave IK-930 an initial safety rating of 1 due to its lack of documented effectiveness and limited evidence regarding potential risks."
Is there an open enrollment period for this research project?
"Affirmative. The information available on clinicaltrials.gov demonstrates that enrollment for this trial is still open; it was originally posted in July 2022 and was last amended in June of the same year. A total of 158 participants are needed from 6 different medical centres."
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