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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04857372
Registration number
NCT04857372
Ethics application status
Date submitted
20/04/2021
Date registered
23/04/2021
Date last updated
14/05/2024
Titles & IDs
Public title
A Phase I Study of IAG933 in Patients With Advanced Mesothelioma and Other Solid Tumors
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Scientific title
An Open-label, Multi-center, Phase I Study of Oral IAG933 in Adult Patients With Advanced Mesothelioma and Other Solid Tumors
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Secondary ID [1]
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CIAG933A12101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mesothelioma
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - IAG933
Experimental: Group 1 - Malignant pleural mesothelioma
Experimental: Group 2 - NF2 truncating mutations or deletions
Experimental: Group 3 - Solid tumors with functional YAP/TAZ fusions
Experimental: Group 4 - Non-pleural mesothelioma
Treatment: Drugs: IAG933
Capsule
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of patients with adverse events and serious adverse events
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Assessment method [1]
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Safety and tolerability of IAG933
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Timepoint [1]
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3 years
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Primary outcome [2]
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Incidence of dose limiting toxicities during the first treatment cycle (dose escalation only)
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Assessment method [2]
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Safety, tolerability and the maximum tolerated dose or recommended dose of IAG933
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Timepoint [2]
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1 year
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Primary outcome [3]
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Number of patients with dose interruptions and dose changes
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Assessment method [3]
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Tolerability of IAG933
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Timepoint [3]
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3 years
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Secondary outcome [1]
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Overall response rate (ORR)
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Assessment method [1]
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Assess anti-tumor activity as per RECIST v1.1 and mRECIST v1.1 (for the malignant pleural mesothelioma patients), and RANO (for patients with primary brain/CNS tumors)
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Timepoint [1]
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3 years
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Secondary outcome [2]
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Disease control rate (DCR)
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Assessment method [2]
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Assess anti-tumor activity as per RECIST v1.1 and mRECIST v1.1 (for the malignant pleural mesothelioma), and RANO (for patients with primary brain/CNS tumors)
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Timepoint [2]
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3 years
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Secondary outcome [3]
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Progression free survival (PFS)
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Assessment method [3]
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Assess anti-tumor activity as per RECIST v1.1 and mRECIST v1.1 (for the malignant pleural mesothelioma patients), and RANO (for patients with primary brain/CNS tumors)
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Timepoint [3]
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3 years
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Secondary outcome [4]
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Duration of response (DOR)
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Assessment method [4]
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Assess anti-tumor activity as per RECIST v1.1 and mRECIST v1.1 (for the malignant pleural mesothelioma patients), and RANO (for patients with primary brain/CNS tumors)
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Timepoint [4]
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3 years
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Secondary outcome [5]
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Overall survival (OS) (dose expansion only)
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Assessment method [5]
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Assess anti-tumor activity as per RECIST v1.1 and mRECIST v1.1 (for the malignant pleural mesothelioma patients), and RANO (for patients with primary brain/CNS tumors)
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Timepoint [5]
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3 years
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Secondary outcome [6]
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Minimum serum concentration (Cmin) (dose escalation only)
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Assessment method [6]
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Characterize PK of IAG933
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Timepoint [6]
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1 year
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Secondary outcome [7]
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Maximum serum concentration (Cmax)
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Assessment method [7]
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Characterize PK of IAG933
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Timepoint [7]
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3 years
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Secondary outcome [8]
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Time to reach Cmax (Tmax)
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Assessment method [8]
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Characterize PK of IAG933
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Timepoint [8]
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3 years
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Secondary outcome [9]
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Area under the curve (AUC)
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Assessment method [9]
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Characterize PK of IAG933
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Timepoint [9]
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3 years
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Secondary outcome [10]
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Half life (T1/2) (dose escalation only)
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Assessment method [10]
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Characterize PK of IAG933
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Timepoint [10]
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1 year
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Secondary outcome [11]
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Accumulation ratio (Racc) (dose escalation only)
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Assessment method [11]
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Characterize PK of IAG933
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Timepoint [11]
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1 year
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Eligibility
Key inclusion criteria
1. Signed informed consent must be obtained prior to participation in the study.
2. Male or female patients must be = 18 years of age.
3. Dose escalation part: patients with histologically or cytologically confirmed
diagnosis of advanced (unresectable or metastatic) mesothelioma or other solid tumors.
Patients with solid tumors other than mesothelioma must have local available data for
loss-of-function NF2/LATS1/LATS2 genetic alterations (truncating mutation or gene
deletion; LATS1/LATS2 mutations will only be included in the dose escalation part), or
functional YAP/TAZ fusions. Patients with malignant EHE can be enrolled with only
histological confirmation of the disease. Patients must have failed available standard
therapies, be intolerant of or ineligible for standard therapy, or for whom no
standard therapy exists.
4. Dose expansion part: the following patients will be enrolled into 3 different
treatment groups:
Group 1: Advanced (unresectable or metastatic) MPM patients who have failed available
standard therapies for advanced/metastatic disease, be intolerant or ineligible to
receive such therapy, or for whom no standard therapy exists.
Group 2: Advanced (unresectable or metastatic) solid tumor patients with available
local data for NF2 truncating mutation or deletions. Patient must have failed
available standard therapies, be intolerant or ineligible to receive such therapy, or
for whom no standard therapy exists.
Group 3: Advanced (unresectable or metastatic) solid tumor patients with available
local data for functional YAP/TAZ fusions. EHE patients can be included with only
histological confirmation of the disease. Patient must have failed available standard
therapies, be intolerant or ineligible to receive such therapy, or for whom no
standard therapy exists.
Group 4: Advanced (unresectable or metastatic) non-pleural mesothelioma patients who
have failed available standard therapies for advanced/metastatic disease, are
intolerant or ineligible to receive such therapy, or for whom no standard therapy
exists.
5. Presence of at least one measurable lesion according to mRECIST v1.1 for mesothelioma
patients, RECIST v1.1 for patients with other solid tumors, or RANO for patients with
primary brain tumors.
6. Patient must have a site of disease amenable to biopsy and be a candidate for tumor
biopsy according to the treating institution's guidelines. Patient must be willing to
undergo a new tumor biopsy at screening/baseline, and again during therapy on this
study.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Treatment with any of the following anti-cancer therapies prior to the first dose of
study treatment within the stated timeframes:
1. = 4 weeks for thoracic radiotherapy to lung fields or limited field radiation for
palliation within = 2 weeks prior to the first dose of study treatment. An
exception to this exists for patients who have received palliative radiotherapy
to bone, who must have recovered from radiotherapy-related toxicities but for
whom a 2-week washout period is not required.
2. = 4 weeks or = 5 half-lives (whichever is shorter) for chemotherapy or biological
therapy (including monoclonal antibodies) or continuous or intermittent small
molecule therapeutics or any other investigational agent.
3. = 6 weeks for cytotoxic agents with risk of major delayed toxicities, such as
nitrosoureas and mitomycin C.
4. = 4 weeks for immuno-oncologic therapy, such as CTLA4, PD-1, or PD-L1 antagonists
5. Prior treatment with TEAD inhibitor at any time
2. For mesothelioma patients: use of non-invasive antineoplastic therapy (e.g., tumor
treating fields, brand name Optune LuaTM) within 2 weeks of the tumor assessment at
screening.
3. Malignant disease, other than that being treated in this study.
4. Insufficient renal function at Screening.
5. Clinically significant cardiac disease or risk factors at screening
6. Insufficient bone marrow function at screening.
7. Insufficient hepatic function at screening.
8. Patients who have the following laboratory values > Common Terminology Criteria for
Adverse Events (CTCAE) grade 1:
1. Potassium
2. Magnesium
3. Total calcium (corrected for low serum albumin)
9. Known active COVID-19 infection.
10. Pregnant or nursing (lactating) women,
11. Japan only: patients with a history of drug- and/or non-drug-induced interstitial lung
disease (ILD) = Grade 2.
Other protocol-defined inclusion/exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/10/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
6/10/2025
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Actual
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Sample size
Target
156
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Illinois
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Country [2]
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United States of America
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State/province [2]
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Massachusetts
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Country [3]
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United States of America
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State/province [3]
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Ohio
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Country [4]
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United States of America
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State/province [4]
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Texas
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Country [5]
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Canada
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State/province [5]
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Quebec
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Country [6]
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France
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State/province [6]
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Villejuif
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Country [7]
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Germany
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State/province [7]
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Essen
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Country [8]
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Italy
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State/province [8]
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MI
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Country [9]
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Japan
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State/province [9]
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Tokyo
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Country [10]
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Netherlands
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State/province [10]
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Zuid Holland
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Country [11]
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Spain
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State/province [11]
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Catalunya
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Country [12]
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Switzerland
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State/province [12]
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Zuerich
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Country [13]
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United Kingdom
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State/province [13]
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to characterize the safety and tolerability of IAG933 in
patients with mesothelioma, NF2/LATS1/LATS2 mutated tumors and tumors with functional YAP/TAZ
fusions and to identify the maximum tolerated dose and/or recommended dose.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04857372
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Novartis Pharmaceuticals
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Address
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Country
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Phone
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1-888-669-6682
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04857372
Download to PDF