MesotheliomaPhase 1NCT04857372
A Phase I Study of IAG933 in Patients With Advanced Mesothelioma and Other Solid Tumors
A Phase 1 study testing IAG933 in people with Mesothelioma, run by Novartis Pharmaceuticals at 16 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Mesothelioma
- What is being tested?
- IAG933
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 16 sitesin 11 countries
- Study dates
- 21 Oct 2021to 8 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 120 years
- 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 patients must be ≥ 18 years of age.
- 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.
- 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.
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- 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.
- 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.
- 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. An archival tumor sample may be used at screening. During the dose expansion part of the study, a decision may be made to stop the collection of on-treatment biopsies.
Who cannot join
- Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes:
- ≤ 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.
- ≤ 4 weeks or ≤ 5 half-lives (whichever is shorter) for biological therapy (including monoclonal antibodies) or continuous or intermittent small molecule therapeutics or any other investigational agent.
- ≤3 weeks for treatment with cytotoxic agents or ≤ 6 weeks for cytotoxic agents with risk of major delayed toxicities, such as nitrosoureas and mitomycin C.
- ≤ 4 weeks for immuno-oncologic therapy, such as CTLA4, PD-1, or PD-L1 antagonists
- Prior treatment with TEAD inhibitor at any time
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- 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.
- Malignant disease, other than that being treated in this study.
- Insufficient renal function at Screening.
- Clinically significant cardiac disease or risk factors at screening
- Insufficient bone marrow function at screening.
- Insufficient hepatic function at screening.
- Patients who have the following laboratory values > Common Terminology Criteria for Adverse Events (CTCAE) grade 1:
- Potassium
- Magnesium
- Total calcium (corrected for low serum albumin)
- Known active COVID-19 infection.
- Pregnant or nursing (lactating) women,
- 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.
Trial locations and contacts
16 sites in 11 countries.
16 sites in 11 countries
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Uni of Chi Medi Ctr Hema and Onco
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
MD Anderson Cancer Center
Houston, Texas, 77030 4009
University of California LA
Los Angeles, California, 90095
Italy2 sites
Novartis Investigative Site
Milan, MI, 20133
Novartis Investigative Site
Rozzano, MI, 20089
Netherlands1 site
Novartis Investigative Site
Rotterdam, South Holland, 3015 GD
About this study
Official title: An Open-label, Multi-center, Phase I Study of Oral IAG933 in Adult Patients With Advanced Mesothelioma and Other Solid Tumors
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.
Read the detailed description
This is a phase I, open-label, multi-center study of IAG933 as a single agent consisting of a dose escalation part, followed by a dose expansion part. The escalation part will characterize the safety and tolerability. After the determination of the recommended dose/maximum tolerated dose, dose expansion will assess the preliminary anti-tumor activity in defined patient populations and further assess the safety and tolerability at RD/MTD.
- Conditions
- Mesothelioma
- Being tested
- IAG933
- Keywords
- Mesothelioma, IAG933, NF2 mutated tumors, LATS1/LATS2 mutated tumors, YAP/TAZ
- Medical subject headings
- Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IAG933Drug
Capsule
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Malignant pleural mesothelioma Receives: Drug: IAG933 |
| Group 2 | Experimental | NF2 truncating mutations or deletions Receives: Drug: IAG933 |
| Group 3 | Experimental | Solid tumors with functional YAP/TAZ fusions Receives: Drug: IAG933 |
| Group 4 | Experimental | Non-pleural mesothelioma Receives: Drug: IAG933 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events and serious adverse events
Safety and tolerability of IAG933
Measured: 3 years
Incidence of dose limiting toxicities during the first treatment cycle (dose escalation only)
Safety, tolerability and the maximum tolerated dose or recommended dose of IAG933
Measured: 1 year
Number of patients with dose interruptions and dose changes
Tolerability of IAG933
Measured: 3 years
Secondary outcomes (11)
Overall response rate (ORR)
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)
Measured: 3 years
Disease control rate (DCR)
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)
Measured: 3 years
Progression free survival (PFS)
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)
Measured: 3 years
Duration of response (DOR)
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)
Measured: 3 years
Overall survival (OS) (dose expansion only)
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)
Measured: 3 years
Minimum serum concentration (Cmin) (dose escalation only)
Characterize PK of IAG933
Measured: 1 year
Maximum serum concentration (Cmax)
Characterize PK of IAG933
Measured: 3 years
Time to reach Cmax (Tmax)
Characterize PK of IAG933
Measured: 3 years
Area under the curve (AUC)
Characterize PK of IAG933
Measured: 3 years
Half life (T1/2) (dose escalation only)
Characterize PK of IAG933
Measured: 1 year
Accumulation ratio (Racc) (dose escalation only)
Characterize PK of IAG933
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start21 Oct 2021
- Primary completion7 Jan 2027 (estimated)
- Study completion8 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MesotheliomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857372
- Sponsor's protocol ID
- CIAG933A12101
- Status last verified
- Jun 2026
- First submitted
- 20 Apr 2021
- Last updated
- 22 Jun 2026
- 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 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Phase I Study of Oral IAG933 in Adult Patients With Advanced Mesothelioma and Other Solid Tumors
- ClinicalTrials.gov ID
- NCT04857372
- Acronym / sponsor ID
- CIAG933A12101
- Conditions
- Mesothelioma
- Keywords
- Mesothelioma, IAG933, NF2 mutated tumors, LATS1/LATS2 mutated tumors, YAP/TAZ
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 7 Jan 2027 (estimated)
- Study completion
- 8 Jan 2027 (estimated)
- First posted
- 23 Apr 2021 (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.
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.
Detailed description
This is a phase I, open-label, multi-center study of IAG933 as a single agent consisting of a dose escalation part, followed by a dose expansion part. The escalation part will characterize the safety and tolerability. After the determination of the recommended dose/maximum tolerated dose, dose expansion will assess the preliminary anti-tumor activity in defined patient populations and further assess the safety and tolerability at RD/MTD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: IAG933Malignant pleural mesothelioma |
| Group 2 | Experimental | Drug: IAG933NF2 truncating mutations or deletions |
| Group 3 | Experimental | Drug: IAG933Solid tumors with functional YAP/TAZ fusions |
| Group 4 | Experimental | Drug: IAG933Non-pleural mesothelioma |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent must be obtained prior to participation in the study.
- Male or female patients must be ≥ 18 years of age.
- 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.
- 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.
Key exclusion criteria (20 listed)
- Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes:
- 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.
- Malignant disease, other than that being treated in this study.
- Insufficient renal function at Screening.
- Clinically significant cardiac disease or risk factors at screening
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 |
|---|---|---|
| IAG933Capsule | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Number of patients with adverse events and serious adverse events
Time frame: 3 years
Safety and tolerability of IAG933
Incidence of dose limiting toxicities during the first treatment cycle (dose escalation only)
Time frame: 1 year
Safety, tolerability and the maximum tolerated dose or recommended dose of IAG933
Number of patients with dose interruptions and dose changes
Time frame: 3 years
Tolerability of IAG933
11 secondary outcomes
Overall response rate (ORR)
Time frame: 3 years
Disease control rate (DCR)
Time frame: 3 years
Progression free survival (PFS)
Time frame: 3 years
Duration of response (DOR)
Time frame: 3 years
Overall survival (OS) (dose expansion only)
Time frame: 3 years
Minimum serum concentration (Cmin) (dose escalation only)
Time frame: 1 year
Maximum serum concentration (Cmax)
Time frame: 3 years
Time to reach Cmax (Tmax)
Time frame: 3 years
Area under the curve (AUC)
Time frame: 3 years
Half life (T1/2) (dose escalation only)
Time frame: 1 year
Accumulation ratio (Racc) (dose escalation only)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IAG933 in people with Mesothelioma, run by Novartis Pharmaceuticals at 16 sites in 11 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 10 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Italy, Australia, Canada, France and 6 more countries. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of patients with adverse events and serious adverse events (time frame: 3 years). 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 22 Jun 2026.