Solid Tumors, AdultPhase 1NCT05228015
Oral TEAD Inhibitor Targeting the Hippo Pathway in Subjects with Advanced Solid Tumors
A Phase 1 study testing IK-930 and Osimertinib in people with Solid Tumors, Adult and Solid Tumor, run by Ikena Oncology at 12 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Adult, Solid Tumor, Malignant Pleural Mesothelioma (MPM)
- What is being tested?
- IK-930 and Osimertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 7 Jan 2022to 9 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent must be obtained prior to participation in the study.
- Male or female subjects ≥ 18 years of age.
- 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.
- 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.
- In the Dose expansion: Four groups of subjects will be enrolled:
- Cohort 1: Subjects with histological confirmed MPM and that have documented NF2 deficiency,
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- 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. 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.
- 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.
- Subjects can have measurable or evaluable disease by RECIST 1.1 criteria as assessed by the Investigator/local radiologist.
Who cannot join
- 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)
- Subjects with leptomeningeal metastases are excluded
- Uncontrolled or life-threatening symptomatic concomitant disease
- Clinically significant cardiovascular disease as defined in the protocol
- Women who are pregnant or breastfeeding
- Subjects who are unable to swallow or retain oral medication
- Prior treatment/exposure to YAP/TAZ/TEAD inhibitors
- Other inclusion/exclusion criteria may apply
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States9 sites
Massachusetts General Hospital
Boston, Massachusetts, 02215
The University of Chicago
Chicago, Illinois, 60637
Start Midwest
Grand Rapids, Michigan, 49546
MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Next Oncology
San Antonio, Texas, 78229
United Kingdom2 sites
University Hospitals of Leicester NHS Trust
Leicester, England, LE1 5WW
The Royal Marsden Hospital
London, England, SW3 6JJ
Australia1 site
Peninsula South Eastern Haematology and Oncology Group (PASO Medical)
Frankston, Victoria, 3199
About this study
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
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.
- Conditions
- Solid Tumors, Adult, Solid Tumor, Malignant Pleural Mesothelioma (MPM), Epithelioid Hemangioendothelioma (EHE), NF2 Deficient Mesothelioma, Other NF2 Deficient Solid Tumors and Solid Tumors with YAP1/TAZ Fusion Genes
- Being tested
- IK-930, Osimertinib
- Keywords
- IK-930, HIPPO Pathway, TEAD, YAP/TAZ, NF2 mutated tumors
- Medical subject headings
- Mesothelioma, Malignant, Hemangioendothelioma, Epithelioid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IK-930Drug
tablets for oral administration
OsimertinibDrug
tablets for oral administration
| Study group | Role | What they receive |
|---|---|---|
| IK-930 Single Agent Dose Escalation | Experimental | Not described Receives: Drug: IK-930 |
| IK-930 Single Agent Dose Expansion | Experimental | Not described Receives: Drug: IK-930 |
| IK-930 and Osimertinib Combination Dose Escalation | Experimental | Not described Receives: Drug: IK-930; Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of IK-930
The frequency and severity, incidence of treatment-emergent and treatment-related adverse events using NCI-CTCAE v5.0
Measured: Through study completion, an average of 36 months
Occurrence of Dose Limiting Toxicity during first treatment cycle
Measured: Approximately 1 year
RP2D and/or MTD of IK-930
Define the recommended phase 2 dose (RP2D) and/or MTD of IK-930
Measured: Approximately 1 year
Secondary outcomes (10)
Antitumor activity per RECIST 1.1: Disease control rate (DCR) of IK-930 as a single agent
Measured: Through study completion, average of 36 months
Antitumor activity per RECIST 1.1: Time to response (TTR) of IK-930 as a single agent
Measured: Through study completion, average of 36 months
Antitumor activity per RECIST 1.1: Duration of response (DOR) of IK-930 as a single agent
Measured: Through study completion, average of 36 months
Antitumor activity per RECIST 1.1: Objective response rate (ORR) of IK-930 as a single agent
Measured: Through study completion, average of 36 months
Antitumor activity: Median progression-free survival (PFS) of IK-930 as a single agent
Measured: Through study completion, average of 36 months
Antitumor activity: Median overall survival (OS) of IK-930 as a single agent
Measured: Through study completion, average of 36 months
Pharmacokinetics of IK-930: half-life (t1/2)
Measured: Approximately 1 year
Pharmacokinetics of IK-930: Area Under the Curve (AUC)
Measured: Approximately 1 year
Pharmacokinetics of IK-930: Maximum Plasma Concentration (Cmax)
Measured: Approximately 1 year
Pharmacokinetics of IK-930: Minimum Plasma Concentration (Cmin)
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start7 Jan 2022
- Primary completion27 Aug 2024
- Study completion9 Sep 2024
Why it stopped: Sponsor strategic reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Part 1 dose escalation: BOIN design; Part 2 dose expansion: 4 parallel cohorts, Simon 2-stage
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ikena Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katherine Kim, MD, Study director, Ikena OncologyCaroline Germa, MD, Study chair, Ikena Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228015
- Sponsor's protocol ID
- IK930-001
- Status last verified
- Nov 2024
- First submitted
- 7 Jan 2022
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05228015
- Acronym / sponsor ID
- IK930-001
- Conditions
- Solid Tumors, Adult, Solid Tumor, Malignant Pleural Mesothelioma (MPM), Epithelioid Hemangioendothelioma (EHE), NF2 Deficient Mesothelioma, Other NF2 Deficient Solid Tumors and Solid Tumors with YAP1/TAZ Fusion Genes
- Keywords
- IK-930, HIPPO Pathway, TEAD, YAP/TAZ, NF2 mutated tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor strategic reasons
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Ikena OncologyIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Part 1 dose escalation: BOIN design; Part 2 dose expansion: 4 parallel cohorts, Simon 2-stage
| Arm | Type | Receives |
|---|---|---|
| IK-930 Single Agent Dose Escalation | Experimental | Drug: IK-930 |
| IK-930 Single Agent Dose Expansion | Experimental | Drug: IK-930 |
| IK-930 and Osimertinib Combination Dose Escalation | Experimental | Drug: IK-930, Drug: Osimertinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed informed consent must be obtained prior to participation in the study.
- Male or female subjects ≥ 18 years of age.
- 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.
- 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.
- In the Dose expansion: Four groups of subjects will be enrolled:
Key exclusion criteria (8 listed)
- 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)
- Uncontrolled or life-threatening symptomatic concomitant disease
- Clinically significant cardiovascular disease as defined in the protocol
- Women who are pregnant or breastfeeding
- Subjects who are unable to swallow or retain oral medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IK-930tablets for oral administration | Drug | IK-930 Single Agent Dose Escalation, IK-930 Single Agent Dose Expansion, IK-930 and Osimertinib Combination Dose Escalation |
| Osimertinibtablets for oral administration | Drug | IK-930 and Osimertinib Combination Dose Escalation |
Primary outcome
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
Occurrence of Dose Limiting Toxicity during first treatment cycle
Time frame: Approximately 1 year
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
10 secondary outcomes
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
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
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
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
Antitumor activity: Median progression-free survival (PFS) of IK-930 as a single agent
Time frame: Through study completion, average of 36 months
Antitumor activity: Median overall survival (OS) of IK-930 as a single agent
Time frame: Through study completion, average of 36 months
Pharmacokinetics of IK-930: half-life (t1/2)
Time frame: Approximately 1 year
Pharmacokinetics of IK-930: Area Under the Curve (AUC)
Time frame: Approximately 1 year
Pharmacokinetics of IK-930: Maximum Plasma Concentration (Cmax)
Time frame: Approximately 1 year
Pharmacokinetics of IK-930: Minimum Plasma Concentration (Cmin)
Time frame: Approximately 1 year
Results and safety
The study was stopped early (reason given: Sponsor strategic reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Kim, MD study director
Ikena Oncology
Caroline Germa, MD study chair
Ikena Oncology
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IK-930 and Osimertinib in people with Solid Tumors, Adult and Solid Tumor, run by Ikena Oncology at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, United Kingdom, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor strategic reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of IK-930 (time frame: Through study completion, an average of 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.