TerminatedPhase 1NCT05228015
Official study title

Oral TEAD Inhibitor Targeting the Hippo Pathway in Subjects with Advanced Solid Tumors

Study summary

This is a Phase 1, first-in-human (FIH) clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of IK-930, an oral TEAD inhibitor, administered orally (PO) as monotherapy in subjects with advanced solid tumors with or without gene alterations in the Hippo pathway for whom there are no further treatment options known to confer clinical benefit. The study consists of two phases, an initial Dose Escalation phase followed by a Dose Expansion phase.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedIK-930 and Osimertinib

The study team can explain what participation involves.

Who it may be forMesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 18, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?12 U.S. locations

Locations may change over time.

Who runs it?Ikena Oncology

Study sponsor

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Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Ikena Oncology
Interventions being studied
Drug: IK-930; Drug: Osimertinib
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Treatment approach
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. Signed informed consent must be obtained prior to participation in the study. 2. Male or female subjects ≥ 18 years of age. 3. If feasible, subjects must be willing to consent to the submission of formalin-fixed paraffin-embedded tissue blocks or slides of tumor tissue, preferably from pre-treatment, baseline fresh tumor biopsy at Screening. Alternatively, archival tumor FFPE blocks or, unstained slides of tumor tissue from available archival sources are acceptable. 4. In the dose escalation cohort: Subjects with histologically proven advanced, unresectable, locally recurrent, or metastatic malignancy that has progressed on or following standard-of-care therapies and for whom there is no available therapy known to confer clinical benefit, regardless of the presence or absence of NF2 deficiency or other genetic alterations of the Hippo pathway. Subjects with histological confirmation of MPM; subjects with NF2-deficient MPM determined by local test results for testing can also be enrolled as well as subjects with any other solid tumors with documented NF2 deficiency determined by local test results for testing, including, but not limited to, meningioma, cholangiocarcinoma, thymoma, mucoepidermoid NSCLC, HCC, and others. Subjects diagnosed with EHE with documented TAZ-CAMTA1 or YAP1-TFE3 gene fusions, as determined by local tests and subjects with solid tumors who have YAP1/TAZ gene fusions as determined by local test results can also be enrolled in the dose escalation part of the study. 5. In the Dose expansion: Four groups of subjects will be enrolled: 1. Cohort 1: Subjects with histological confirmed MPM and that have documented NF2 deficiency, 2. 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. 3. 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. Subjects who have objective disease progression to prior therapy or have active disease and cancer-related pain requiring narcotics for management are eligible. 4. Cohort 4: Subjects with any solid tumor with documented YAP1/TAZ gene fusions as determined by local test results. 6. In the Osimertinib Combination Cohort subjects must have a histologically proven, incurable, locally advanced or metastatic NSCLC expressing osimertinib-sensitive EGFR mutations; have evidence of radiological disease progression on prior receipt of Osimertinib and have progressed on additional anticancer therapy such as chemotherapy. 7. Subjects can have measurable or evaluable disease by RECIST 1.1 criteria as assessed by the Investigator/local radiologist.

Reasons someone may not be able to joinExclusion criteria

1. Subjects with untreated or symptomatic primary central nervous system (CNS) tumors or with intracranial metastases (excluding primary CNS tumors that may be eligible for enrollment as part of Cohort 2 e.g., NF-2 deficient meningioma) a. Subjects with leptomeningeal metastases are excluded 2. Uncontrolled or life-threatening symptomatic concomitant disease 3. Clinically significant cardiovascular disease as defined in the protocol 4. Women who are pregnant or breastfeeding 5. Subjects who are unable to swallow or retain oral medication 6. Prior treatment/exposure to YAP/TAZ/TEAD inhibitors 7. Other inclusion/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • The University of ChicagoChicago, Illinois
  • Massachusetts General HospitalBoston, Massachusetts
  • Start MidwestGrand Rapids, Michigan
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • University of Pennsylvania Abramson Cancer CenterPhiladelphia, Pennsylvania
  • Sidney Kimmel Cancer Center at Thomas Jefferson University HospitalPhiladelphia, Pennsylvania
  • Sarah Cannon Research InstituteNashville, Tennessee
  • MD Anderson Cancer CenterHouston, Texas
  • Next OncologySan Antonio, Texas
  • Peninsula South Eastern Haematology and Oncology Group (PASO Medical)Frankston, Victoria
  • University Hospitals of Leicester NHS TrustLeicester, England
  • The Royal Marsden HospitalLondon, England

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 18, 2024. Always confirm current availability with the study team.

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