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TEAD Inhibitor

TEAD Inhibitor for Solid Cancers

Phase 1
Recruiting
Research Sponsored by Ikena Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If feasible, subjects must be willing to consent to the submission of formalin-fixed paraffin-embedded tissue blocks of tumor tissue, preferably from pre-treatment fresh tumor biopsy. Alternatively, archival tumor FFPE blocks or, preferably, 10 unstained slides of tumor tissue from available archival sources are acceptable
In the Dose expansion: Four groups of subjects will be enrolled: Cohort 1: Subjects with histological confirmed MPM and that have documented NF2 deficiency, Cohort 2: Subjects with other documented NF2-deficient solid tumors agnostic to tumor type including, but not limited to, meningioma, cholangiocarcinoma, thymoma, NSCLC, HCC, and others. Cohort 3: Subjects with histopathological diagnosis of epithelioid hemangioendothelioma (EHE) and documented TAZ-CAMTA1 or YAP1-TFE3 gene fusions, as determined by local test results for RNA-seq, FISH or IHC. Subjects who have objective disease progression to prior therapy or have active disease and cancer-related pain requiring narcotics for management are eligible. Cohort 4: Subjects with any solid tumor with documented YAP1/TAZ gene fusions as determined by local test results for RNA-seq, FISH or IHC. Subjects can have measurable or evaluable disease by RECIST 1.1 criteria as assessed by the Investigator/local radiologist. Comply with the study protocol and with the planned biopsy procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 1 year
Awards & highlights

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.

Who is the study for?
Adults with advanced solid tumors, including mesothelioma and neurofibromatosis type 2, who have no other treatment options. Participants must be able to take oral medication and consent to tumor tissue submission. Specific groups include those with NF2 deficiency or gene fusions in the Hippo pathway.Check my eligibility
What is being tested?
IK-930, an oral TEAD inhibitor targeting the Hippo pathway, is being tested for safety and effectiveness in two phases: Dose Escalation to find a safe dosage level followed by Dose Expansion to further assess its impact on various advanced solid tumors.See study design
What are the potential side effects?
While specific side effects of IK-930 are not listed here as it's first-in-human use, potential risks may include typical drug reactions such as nausea, fatigue, allergic responses or more serious complications depending on how it affects the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to provide tissue samples from my tumor for the study.
Select...
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.
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I have advanced cancer with no standard treatment options left.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of Dose Limiting Toxicity during first treatment cycle
RP2D and/or MTD of IK-930
Safety and tolerability of IK-930
Secondary outcome measures
Antitumor activity per RECIST 1.1: Disease control rate (DCR) of IK-930 as a single agent
Antitumor activity per RECIST 1.1: Duration of response (DOR) of IK-930 as a single agent
Antitumor activity per RECIST 1.1: Objective response rate (ORR) of IK-930 as a single agent
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Experimental: IK-930 Single Agent Dose ExpansionExperimental Treatment1 Intervention
Group II: Experimental: IK-930 Single Agent Dose EscalationExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Ikena OncologyLead Sponsor
5 Previous Clinical Trials
441 Total Patients Enrolled
Karim Malek, MDStudy DirectorIkena Oncology
2 Previous Clinical Trials
78 Total Patients Enrolled
Sergio Santillana, MD, MScStudy ChairIkena Oncology
1 Previous Clinical Trials
150 Total Patients Enrolled

Media Library

IK-930 (TEAD Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05228015 — Phase 1
Neurofibromatosis Research Study Groups: Experimental: IK-930 Single Agent Dose Escalation, Experimental: IK-930 Single Agent Dose Expansion
Neurofibromatosis Clinical Trial 2023: IK-930 Highlights & Side Effects. Trial Name: NCT05228015 — Phase 1
IK-930 (TEAD Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05228015 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~30 spots leftby Oct 2024