Active not recruitingPHASE1INTERVENTIONAL

A Phase I Study of IAG933 in Patients With Advanced Mesothelioma and Other Solid Tumors

This research study is investigating a new medication called IAG933. It's for adults aged 18 and over who have advanced mesothelioma or certain other solid cancers that have specific genetic changes. The main goals are to understand the side effects of IAG933, determine the safest and most effective dose, and see if it helps to control the cancer's growth. Participants will be those for whom standard treatments haven't worked, aren't tolerated, or where there are no other treatment options. The study will happen in two parts: first, finding the right dose, and then, expanding to more patients to further check its safety and how well it fights cancer.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Novartis Pharmaceuticals

Enrolment target

137

Start

21 Oct 2021

Estimated completion

04 Sep 2026

Mesothelioma

What is this study about?

This study is focusing on a new medicine called IAG933. It's being tested in people with advanced mesothelioma, which is a type of cancer that affects the lining of some organs, most commonly the lungs. It's also for people with other solid cancers that have particular genetic changes (alterations in genes called NF2, LATS1, LATS2, or YAP/TAZ). The term 'advanced' means the cancer may have spread or cannot be removed by surgery.

The main purpose of this study is to find out if IAG933 is safe, what side effects it might cause, and what the best dose is. This is known as a 'Phase I' study, which means it's one of the first times this new drug is being given to people. Researchers will be carefully monitoring participants to understand how their bodies react to the medication. After finding a safe dose, the study will expand to include more people to get a better idea of how well IAG933 might fight these specific cancers.

Taking part in a study like this is important because it helps scientists learn more about new treatments. This information can lead to new and better ways to treat these cancers in the future, especially for people whose current treatments are no longer working or aren't an option for them. It's a key step in developing potential new therapies.

Key takeaways

This study is testing a new drug, IAG933, for certain advanced cancers.
It aims to find a safe dose and see how well the drug works.
Participants generally have mesothelioma or other cancers with specific gene changes.
It's for people whose standard treatments haven't been successful or are not an option.
This is an early-stage study, closely monitoring safety and side effects.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To join this study, you must be at least 18 years old. All participants must first sign an informed consent form, which means you understand what the study involves and agree to take part.

For the initial part of the study (called 'dose escalation'), we are looking for people with advanced mesothelioma or other solid cancers that have specific genetic changes (in NF2, LATS1, LATS2, or YAP/TAZ genes). You would typically have already tried standard treatments, found them unsuitable, or there are no other standard options available for your cancer. Some patients with a rare cancer called EHE can also join with a simple diagnosis.

Later, in the 'dose expansion' part of the study, specific groups of patients will be included. These groups include those with advanced mesothelioma (both lung-related and other forms), and those with other advanced solid cancers that have specific NF2 gene changes or YAP/TAZ gene changes. Again, for these groups, you should have already received standard treatments that haven't worked, or they aren't an option for you.

Quick self-check

Are you 18 years of age or older?
Do you have advanced mesothelioma or another solid cancer?
Has your cancer been tested for specific gene changes (NF2, LATS1, LATS2, or YAP/TAZ)?
Have you already tried standard treatments for your cancer, or are they not suitable for you?
Are you able and willing to sign an informed consent form?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you will be given the study drug, IAG933. Since this is an 'open-label' study, both you and your doctor will know you are receiving the active drug. The study has two main parts. Initially, a small group of patients will receive gradually increasing doses of IAG933. This part is focused on finding a safe dose and understanding potential side effects.

Once a safe dose is identified, more patients will join the second part of the study. This part will further assess the safety of IAG933 at the chosen dose and also start to look at how effective it is against the cancer. You will have regular hospital visits for assessments, which may include blood tests, scans, and physical examinations, to monitor your health and the cancer's response. The total duration of your participation will depend on how you respond to the treatment and the study's design; your study doctor will explain this in detail.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new treatment (IAG933) that is not yet widely available, especially if standard treatments haven't worked for you. However, as with any new medicine, there are potential risks and side effects that are not yet fully known. These will be carefully monitored by the study team, and you will be informed of any new information. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (16)

University of California LA
Los Angeles, United States
Uni of Chi Medi Ctr Hema and Onco
Chicago, United States
Massachusetts General Hospital
Boston, United States
Cleveland Clinic Foundation
Cleveland, United States
MD Anderson Cancer Center
Houston, United States
Novartis Investigative Site
Melbourne, Australia
Novartis Investigative Site
Montreal, Canada
Novartis Investigative Site
Villejuif, France
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Milan, Italy
Novartis Investigative Site
Rozzano, Italy
Novartis Investigative Site
Chuo Ku, Japan

+4 more sites — see the official record for the full list.

Common questions

What is IAG933?

IAG933 is a new investigational medication being tested in this study for certain types of cancer.

What does 'Phase I study' mean?

A Phase I study is an early stage of clinical research where a new drug is given to people for the first time to primarily check its safety and determine the right dose.

Will I know if I'm getting the active drug?

Yes, this is an 'open-label' study, meaning both you and your study doctor will know that you are receiving IAG933.

What are 'advanced solid tumors'?

These are cancers that originated in a solid organ (not blood cancer) and have grown or spread, and typically cannot be completely removed by surgery.

What if standard treatments haven't worked for me?

This study is specifically for individuals for whom standard cancer treatments are no longer effective, aren't tolerated, or aren't available.