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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05228015




Registration number
NCT05228015
Ethics application status
Date submitted
7/01/2022
Date registered
8/02/2022

Titles & IDs
Public title
Oral TEAD Inhibitor Targeting the Hippo Pathway in Subjects with Advanced Solid Tumors
Scientific 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
Secondary ID [1] 0 0
IK930-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors, Adult 0 0
Solid Tumor 0 0
Malignant Pleural Mesothelioma (MPM) 0 0
Epithelioid Hemangioendothelioma (EHE) 0 0
NF2 Deficient Mesothelioma 0 0
Other NF2 Deficient Solid Tumors and Solid Tumors with YAP1/TAZ Fusion Genes 0 0
NF2 Deficiency 0 0
YAP1 or TAZ Gene Fusions 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Other cancer types
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IK-930
Treatment: Drugs - Osimertinib

Experimental: IK-930 Single Agent Dose Escalation -

Experimental: IK-930 Single Agent Dose Expansion -

Experimental: IK-930 and Osimertinib Combination Dose Escalation -


Treatment: Drugs: IK-930
tablets for oral administration

Treatment: Drugs: Osimertinib
tablets for oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of IK-930
Timepoint [1] 0 0
Through study completion, an average of 36 months
Primary outcome [2] 0 0
Occurrence of Dose Limiting Toxicity during first treatment cycle
Timepoint [2] 0 0
Approximately 1 year
Primary outcome [3] 0 0
RP2D and/or MTD of IK-930
Timepoint [3] 0 0
Approximately 1 year
Secondary outcome [1] 0 0
Antitumor activity per RECIST 1.1: Disease control rate (DCR) of IK-930 as a single agent
Timepoint [1] 0 0
Through study completion, average of 36 months
Secondary outcome [2] 0 0
Antitumor activity per RECIST 1.1: Time to response (TTR) of IK-930 as a single agent
Timepoint [2] 0 0
Through study completion, average of 36 months
Secondary outcome [3] 0 0
Antitumor activity per RECIST 1.1: Duration of response (DOR) of IK-930 as a single agent
Timepoint [3] 0 0
Through study completion, average of 36 months
Secondary outcome [4] 0 0
Antitumor activity per RECIST 1.1: Objective response rate (ORR) of IK-930 as a single agent
Timepoint [4] 0 0
Through study completion, average of 36 months
Secondary outcome [5] 0 0
Antitumor activity: Median progression-free survival (PFS) of IK-930 as a single agent
Timepoint [5] 0 0
Through study completion, average of 36 months
Secondary outcome [6] 0 0
Antitumor activity: Median overall survival (OS) of IK-930 as a single agent
Timepoint [6] 0 0
Through study completion, average of 36 months
Secondary outcome [7] 0 0
Pharmacokinetics of IK-930: half-life (t1/2)
Timepoint [7] 0 0
Approximately 1 year
Secondary outcome [8] 0 0
Pharmacokinetics of IK-930: Area Under the Curve (AUC)
Timepoint [8] 0 0
Approximately 1 year
Secondary outcome [9] 0 0
Pharmacokinetics of IK-930: Maximum Plasma Concentration (Cmax)
Timepoint [9] 0 0
Approximately 1 year
Secondary outcome [10] 0 0
Pharmacokinetics of IK-930: Minimum Plasma Concentration (Cmin)
Timepoint [10] 0 0
Approximately 1 year

Eligibility
Key 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 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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. Prior treatment/exposure to YAP/TAZ/TEAD inhibitors
7. Other inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/09/2024
Sample size
Target
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peninsula South Eastern Haematology and Oncology Group (PASO Medical) - Frankston
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United Kingdom
State/province [8] 0 0
England

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ikena Oncology
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Katherine Kim, MD
Address 0 0
Ikena Oncology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05228015