We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT05228015
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05228015
Recruitment Status : Recruiting
First Posted : February 8, 2022
Last Update Posted : January 26, 2023
Sponsor:
Information provided by (Responsible Party):
Ikena Oncology

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Solid Tumors, Adult Solid Tumor Mesothelioma (MPM) Epithelioid Hemangioendothelioma (EHE) NF2 Deficient Mesothelioma Other NF2 Deficient Solid Tumors and Solid Tumors With YAP1/TAZ Fusion Genes NF2 Deficiency YAP1 or TAZ Gene Fusions Drug: IK-930 Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Part 1 dose escalation: BOIN design; Part 2 dose expansion: 4 parallel cohorts, Simon 2-stage
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, First-in-Human Study of IK-930, an Oral TEAD Inhibitor Targeting the Hippo Pathway in Subjects With Advanced Solid Tumors
Actual Study Start Date : January 7, 2022
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Experimental: IK-930 Single Agent Dose Escalation Drug: IK-930
tablets for oral administration
Experimental: Experimental: IK-930 Single Agent Dose Expansion Drug: IK-930
tablets for oral administration


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Safety and tolerability of IK-930 [ Time Frame: Through study completion, an average of 36 months ]
    The frequency and severity, incidence of treatment-emergent and treatment-related adverse events using NCI-CTCAE v5.0

  2. Occurrence of Dose Limiting Toxicity during first treatment cycle [ Time Frame: Approximately 1 year ]
  3. RP2D and/or MTD of IK-930 [ Time Frame: Approximately 1 year ]
    Define the recommended phase 2 dose (RP2D) and/or MTD of IK-930


Secondary Outcome Measures :
  1. Antitumor activity per RECIST 1.1: Disease control rate (DCR) of IK-930 as a single agent [ Time Frame: Through study completion, average of 36 months ]
  2. Antitumor activity per RECIST 1.1: Time to response (TTR) of IK-930 as a single agent [ Time Frame: Through study completion, average of 36 months ]
  3. Antitumor activity per RECIST 1.1: Duration of response (DOR) of IK-930 as a single agent [ Time Frame: Through study completion, average of 36 months ]
  4. Antitumor activity per RECIST 1.1: Objective response rate (ORR) of IK-930 as a single agent [ Time Frame: Through study completion, average of 36 months ]
  5. Antitumor activity: Median progression-free survival (PFS) of IK-930 as a single agent [ Time Frame: Through study completion, average of 36 months ]
  6. Antitumor activity: Median overall survival (OS) of IK-930 as a single agent [ Time Frame: Through study completion, average of 36 months ]
  7. Pharmacokinetics of IK-930: half-life (t1/2) [ Time Frame: Approximately 1 year ]
  8. Pharmacokinetics of IK-930: Area Under the Curve (AUC) [ Time Frame: Approximately 1 year ]
  9. Pharmacokinetics of IK-930: Maximum Plasma Concentration (Cmax) [ Time Frame: Approximately 1 year ]
  10. Pharmacokinetics of IK-930: Minimum Plasma Concentration (Cmin) [ Time Frame: Approximately 1 year ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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 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.
  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 RNA-seq, FISH or IHC and subjects with solid tumors who have YAP1/TAZ gene fusions as determined by RNA-seq, FISH or IHC, as documented 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 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.
    4. 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.
  6. Subjects can have measurable or evaluable disease by RECIST 1.1 criteria as assessed by the Investigator/local radiologist.
  7. Comply with the study protocol and with the planned biopsy procedures.

Exclusion 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. Other inclusion/exclusion criteria may apply
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05228015


Contacts
Layout table for location contacts
Contact: Dan Culp 857-567-9457 dculp@ikenaoncology.com
Contact: Jennifer Schroeder 857-419-6991 jschroeder@ikenaoncology.com

Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Gregory Cote, MD, PhD    617-724-4000      
Principal Investigator: Gregory Cote, MD, PhD         
United States, Michigan
Start Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Yvette Cole, BSN    616-389-1652    yvette.cole@startmidwest.com   
Principal Investigator: Nehal Lakhani, MD, PhD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Mrinal Gounder, MD    646-888-4167    gounderm@mskcc.org   
Principal Investigator: Mrinal Gounder, MD         
United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: AskPhase1    267-624-6467    askPhase1@jefferson.edu   
Principal Investigator: Babar Bashir, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Phouvong Khounthy    615-934-8804    Phouvong.khounthy@sarahcannon.com   
Principal Investigator: Meredith McKean, MD, MPH         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Gracy Zacharian, RN    713-792-2669    gzachari@mdanderson.org   
Contact: Aaron Reckeweg    (713) 794-4274    asreckew@mdanderson.org   
Principal Investigator: Vinod Ravi, MD         
Next Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Cynthia De Leon    210-580-9521    cdeleon@nextoncology.com   
Principal Investigator: Anthony Tolcher, MD         
Sponsors and Collaborators
Ikena Oncology
Investigators
Layout table for investigator information
Study Director: Karim Malek, MD Ikena Oncology
Study Chair: Sergio Santillana, MD, MSc Ikena Oncology
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ikena Oncology
ClinicalTrials.gov Identifier: NCT05228015    
Other Study ID Numbers: IK930-001
First Posted: February 8, 2022    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ikena Oncology:
IK-930
HIPPO Pathway
TEAD
YAP/TAZ
NF2 mutated tumors
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Mesothelioma
Mesothelioma, Malignant
Hemangioendothelioma
Hemangioendothelioma, Epithelioid
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
 Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases
Hemangioma
Neoplasms, Vascular Tissue