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CAR T-cell Therapy

IAG933 for Mesothelioma

Phase 1
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective in treating mesothelioma, tumors with NF2/LATS1/LATS2 mutations, and tumors with YAP/TAZ fusion.

Who is the study for?
This trial is for adults with advanced mesothelioma or solid tumors that have specific genetic mutations (NF2, LATS1/LATS2) or YAP/TAZ fusions. Participants must have tried all standard treatments without success, be unable to tolerate them, or no standard treatment exists. They should also be able to undergo a tumor biopsy and not have other serious health issues like poor bone marrow, kidney, liver function, significant heart disease risks, active COVID-19 infection or a history of certain lung diseases.Check my eligibility
What is being tested?
The study tests IAG933's safety and tolerability in patients with advanced mesothelioma and other solid tumors. It aims to find the highest dose patients can take without severe side effects (maximum tolerated dose) and suggest an optimal dose for further studies.See study design
What are the potential side effects?
While the exact side effects are not listed here as it's a Phase I trial primarily assessing safety and tolerability, common side effects in such trials may include nausea, fatigue, allergic reactions at the infusion site if applicable, headaches and potentially more depending on how the drug affects the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced mesothelioma and standard treatments haven't worked or aren't suitable for me.
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I have an advanced solid tumor with an NF2 mutation and can't use standard treatments.
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I have an advanced cancer that cannot be surgically removed.
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I can have a biopsy according to my hospital's rules.
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I am willing to have tumor biopsies before and during the study.
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Standard treatments have not worked for me, or I cannot take them.
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I have an advanced solid tumor with YAP/TAZ fusion or EHE confirmed by tests, and standard treatments haven't worked for me.
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My tumor has specific genetic changes not related to mesothelioma.
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I am 18 years old or older.
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My cancer diagnosis was confirmed through tissue examination.
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I have advanced MPM and standard treatments haven't worked or I can't receive them.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose limiting toxicities during the first treatment cycle (dose escalation only)
Number of patients with adverse events and serious adverse events
Number of patients with dose interruptions and dose changes
Secondary outcome measures
Accumulation ratio (Racc) (dose escalation only)
Area under the curve (AUC)
Disease control rate (DCR)
+8 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group 4Experimental Treatment1 Intervention
Non-pleural mesothelioma
Group II: Group 3Experimental Treatment1 Intervention
Solid tumors with functional YAP/TAZ fusions
Group III: Group 2Experimental Treatment1 Intervention
NF2 truncating mutations or deletions
Group IV: Group 1Experimental Treatment1 Intervention
Malignant pleural mesothelioma

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,852 Previous Clinical Trials
4,197,589 Total Patients Enrolled
5 Trials studying Mesothelioma
229 Patients Enrolled for Mesothelioma

Media Library

IAG933 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04857372 — Phase 1
Mesothelioma Research Study Groups: Group 1, Group 4, Group 2, Group 3
Mesothelioma Clinical Trial 2023: IAG933 Highlights & Side Effects. Trial Name: NCT04857372 — Phase 1
IAG933 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04857372 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is admission to this experiment available for participants currently?

"Affirmative. Clinicaltrials.gov confirms that the initial posting of this medical study was on October 21st 2021 and has been actively seeking candidates since, with its most recent edit occuring November 17th 2022. This trial is looking to enrol 156 individuals at 5 sites across the country."

Answered by AI

What are the expected outcomes of this experiment?

"The primary purpose of this study, which is expected to last 3 years, will be assessing the number of patients with adverse and serious adverse events. Secondary aims include calculating the duration of response (DOR) as per RECIST v1.1/mRECIST v1.1 (for malignant pleural mesothelioma), characterizing the pharmacokinetics of IAG933 through accumulation ratio (Racc - dose escalation only), and measuring disease control rate (DCR) according to RECIST v1.1/ mRECIST v 1."

Answered by AI

Does IAG933 present any risks to those taking it medicinally?

"The safety of IAG933, based on the limited evidence from Phase 1 trials, has been estimated to be a 1."

Answered by AI

What are the geographical areas in which this experiment is operational?

"Presently, this trial is operational in 5 locations across the United States and Canada. Sites are hosted in cities such as Boston, Montreal, and Houston. Individuals looking to participate should select a local centre to avoid unnecessary travel costs."

Answered by AI

What is the participant capacity for this research initiative?

"Novartis Pharmaceuticals is responsible for the execution of this trial, which necessitates 156 qualifying patients. The study will be conducted out of Massachusetts General Hospital in Boston and a Novartis Investigative Site located in Montreal, Quebec."

Answered by AI
~60 spots leftby Oct 2025