A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers (NCT04328844) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers
Italy, United Kingdom210 participantsStarted 2020-02-25
Plain-language summary
The objective of study IOA-244-101 is to determine whether IOA-244 is safe and tolerable in cancer patients (Part A). In addition, the study will assess whether IOA-244 can increase the anti-tumour immune response in patients both as monotherapy and in combination pemetrexed/cisplatin/avelumab (Part B Mesothelioma and NSCLC 1st line), in combination with avelumab (Part B Cutaneous Melanoma and NSCLC 2nd/3rd line) and ruxolitinib (Part B Primary Myelofibrosis)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≥18 years of age inclusive, at the time of signing the informed consent.
. Capable of giving signed informed consent, which includes compliance with the requirements of this protocol.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. For patients with NHL, ECOG 2 will be allowed.
. Patients with histologically or cytologically confirmed advanced or metastatic malignancies (including histologically confirmed, unresectable Stage III or IV melanoma); see following details for each malignancy:
. Baseline lactate dehydrogenase levels are available.
. Disease progression is confirmed and they are eligible for second- or third-line treatment:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since IOA-244 is being tested in a Phase 1 trial, which means the main goal right now is figuring out safety rather than proving it works — what do we actually know so far about how safe it has been for patients, and does that change how you'd weigh it against my other options?
2This trial is no longer enrolling new patients — does that mean there's a related follow-up study or a different PI3Kδ inhibitor trial I might be eligible for, given my specific diagnosis?
3IOA-244 is being studied across several very different cancer types, including solid tumors, non-Hodgkin lymphoma, NSCLC, myelofibrosis, and uveal melanoma — given which cancer I have, do you think there's enough early evidence to suggest this drug might be relevant for my situation specifically?
4PI3Kδ inhibitors have shown immune-related side effects in other drugs of this class — based on what's been reported so far for IOA-244, are there particular side effects I should be watching for, and how would those be managed alongside any other treatments I'm receiving?
5Given that this is a Phase 1 study focused on safety, would it make more sense for me to pursue standard treatment first, and then potentially look at experimental options like this if that doesn't work — or is there a reason you'd consider this trial worth prioritizing at this stage of my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Numbers of participants with treatment-related adverse events as assessed by CTCAE v5.0
Timeframe: From time of first drug administration to first documented progression, toxicity or death from any cause whichever occurs first, assessed at week 30