Active not recruitingPHASE1INTERVENTIONAL

A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers

Researchers are conducting a study to learn more about a new medicine called IOA-244 for adults with advanced cancers such as different types of solid tumours, non-Hodgkin lymphoma, and myeloma. The first part of the study focuses on making sure IOA-244 is safe and that people can tolerate it well. The second part will look at whether IOA-244 can boost the body's natural defences against cancer. It will be tested on its own, and also in combination with other established cancer treatments like avelumab, pemetrexed, cisplatin, and ruxolitinib. This helps researchers understand if IOA-244 could be a helpful new treatment option.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

iOnctura

Enrolment target

210

Start

25 Feb 2020

Estimated completion

01 Mar 2027

Solid Tumor, Adult Non-Hodgkin Lymphoma, Adult NSCLC Myelofibrosis Uveal Melanoma

What is this study about?

This research study is looking into a new medicine called IOA-244. Its main goal is to find out if this medicine is safe for people with certain advanced cancers and how well people can tolerate it. This is usually the first step in testing new medicines in humans. Scientists believe IOA-244 might work by helping your body's immune system – its natural defence system – fight against cancer cells more effectively. If the medicine is safe, the researchers will then explore if it can indeed boost this immune response.

The study will test IOA-244 in several ways. Some people will receive IOA-244 on its own. Others will receive it alongside other cancer treatments that are already in use. For example, it might be combined with medicines like avelumab, pemetrexed, cisplatin, or ruxolitinib, depending on the type of cancer. By trying these different combinations, the researchers hope to see if IOA-244 can improve the effectiveness of current treatments.

The hope is that this study will provide important information about IOA-244 and its potential to become a new treatment option for people living with these specific advanced cancers. Understanding how it works and whether it can safely help the immune system fight cancer is a crucial step towards developing more effective therapies in the future.

Key takeaways

Tests a new medicine, IOA-244, for safety in advanced cancers.
Aims to see if IOA-244 helps the immune system fight cancer.
Includes a variety of cancers like lymphoma, melanoma, and lung cancer.
IOA-244 may be given alone or with existing treatments.
It's a Phase 1 study, focusing on early safety and tolerability.

Who may be eligible?

To join this study, you must be at least 18 years old. You should feel well enough to participate in a clinical trial, generally meaning you are able to carry out your day-to-day activities with little to no difficulty. If you have non-Hodgkin lymphoma, you may still be eligible even if you need a bit more help with daily tasks.

This study is for people with certain advanced or metastatic cancers that have been confirmed by a doctor, including different types of melanoma (skin melanoma that has progressed after other treatments, or eye melanoma that has spread), mesothelioma (a type of lung lining cancer), or a specific type of Non-Hodgkin lymphoma called Follicular Lymphoma. You would typically have already received some previous treatments for your cancer.

For some parts of the study, specifically for mesothelioma, you might be considered if you are starting your first course of treatment for the condition. Otherwise, you would generally have already had at least one prior treatment for your cancer and it has either progressed or you're looking for further options.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of advanced solid tumour, non-Hodgkin lymphoma, NSCLC, myelofibrosis, or uveal melanoma?
Are you generally able to carry out most of your daily activities?
Have you already had some treatment for your cancer, or are you starting your first treatment for mesothelioma?

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

What does participation involve?

The information provided in the brief summary does not detail the specific requirements for participation, such as the number of clinic visits, types of assessments (e.g., blood tests, scans), how the medication is given (e.g., pill, injection), the frequency of follow-up appointments, or how long you would be involved in the study from start to finish. This information is crucial for you to understand fully and would be explained in detail by the study team if you express interest.

Potential risks and benefits

Participating in a study like this might offer the potential benefit of accessing a new treatment that isn't yet widely available, which could potentially help your cancer. However, as with any new medicine, there are potential risks, including side effects that are not yet fully known. The study team will carefully monitor you for any side effects. You will receive clear information about all known risks and benefits before deciding to join, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (3)

Humanitas Research Hospital
Rozzano, Italy
Medical Oncology and Immunotherapy Unit, University Hospital of Siena
Siena, Italy
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom

Common questions

What kind of cancer patients are eligible for this study?

This study is for adults with advanced solid tumours, specific types of non-Hodgkin lymphoma, lung cancer (NSCLC), myelofibrosis, and uveal melanoma that have been confirmed by a doctor.

What is IOA-244?

IOA-244 is a new experimental medicine, belonging to a group called PI3Kδ inhibitors, which researchers hope might help the body's immune system fight cancer.

Will I receive IOA-244 by itself or with other medicines?

You might receive IOA-244 on its own, or in combination with other standard cancer treatments, depending on the part of the study and your specific cancer type.

What is the main goal of the study?

The main goals are to find out if IOA-244 is safe and tolerable, and to see if it can improve the body's immune response against cancer.

What does 'Phase 1' mean for a clinical trial?

Phase 1 means this is one of the first times this new medicine is being tested in humans. The main focus is on safety, finding the right dose, and understanding any side effects.