Actuate 1801: Phase 1/2 Study of Elraglusib (9-ING-41), a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, as a Single Agent and Combined with Chemotherapy, in Patients with Refractory Hematologic Malignancies or Solid Tumors
This study is testing an experimental medicine called elraglusib (also known as 9-ING-41) for adults with advanced cancer. It is aimed at people with solid tumours or blood cancers that have returned or stopped responding to standard treatments. Researchers want to find out how safe elraglusib is, how the body handles it, and what dose works best. In this study, elraglusib is given either on its own or together with existing chemotherapy medicines, such as gemcitabine and Abraxane. The main goal is to see if adding elraglusib helps patients live longer and slows down tumour growth compared to standard care. Because this is an early-phase trial, doctors will also carefully monitor any side effects to ensure patient safety throughout treatment.
At a glance
What is this study about?
When cancer returns or stops responding to standard treatments, it is often referred to as 'refractory' cancer. At this stage, doctors look for new ways to target cancer cells that have become resistant to usual medicines. This clinical trial is investigating an experimental medicine called elraglusib (9-ING-41), designed to block a specific protein inside cancer cells known as GSK-3 beta. This protein normally helps cancer cells grow, survive, and resist chemotherapy.
By blocking this protein, researchers hope elraglusib can make cancer cells weaker and more sensitive to treatment. The trial looks at using elraglusib on its own, as well as combining it with established chemotherapy drugs, including gemcitabine and Abraxane. Because these chemotherapy drugs work in different ways, using them alongside elraglusib might provide a more effective attack against difficult-to-treat tumours.
This trial has two main stages, known as Phase 1 and Phase 2. The first part helps doctors find the safest, most effective dose of elraglusib and watch closely for side effects. The second part checks how well the chosen dose works to keep cancer under control, shrink tumours, and help patients live longer, better lives. Research like this is crucial for discovering newer, more effective treatment options for people who have limited choices left.
Key takeaways
- Tests an experimental drug called elraglusib, alone or with chemotherapy.
- Aimed at adults with solid tumours or blood cancers that have stopped responding to standard treatments.
- The main goals are to check safety, find the best dose, and see if it helps patients live longer.
- Medicines are given through a drip at a specialist hospital clinic.
- Participation is entirely voluntary, and you can leave the study at any time.
Who may be eligible?
This study is open to adults aged 18 and older who have been diagnosed with an advanced solid tumour (such as pancreatic, breast, or lung cancer) or a blood cancer (such as leukaemia or lymphoma). To be considered, the cancer must be 'refractory', meaning it has not responded to standard therapies or has returned after previous treatments.
Participants need to be well enough to carry out basic daily activities and have adequate liver, kidney, and bone marrow function. This is necessary so your body can safely handle the trial medicines.
You may not be eligible if you have certain active medical conditions, severe heart problems, or untreated infections. Your hospital cancer specialist will review your full medical history and scan results to see whether this study is safe and appropriate for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- You are aged 18 or older.
- You have a confirmed solid tumour or blood cancer.
- Your cancer has stopped responding to or returned after standard treatments.
- You are well enough to attend regular hospital appointments for treatment and tests.
- Your doctor confirms your kidneys, liver, and heart are functioning well enough for trial medicines.
What does participation involve?
If you take part, your treatment will be given at a hospital or specialist cancer clinic. Elraglusib is given as an infusion into a vein (an intravenous drip), either by itself or along with other chemotherapy drugs on set days of a treatment cycle. You will have regular appointments where doctors will check your general health, carry out blood tests, and ask about any symptoms. Every few cycles, you will have imaging scans (such as CT or MRI scans) to see how your tumour is responding. You can stay on the study for as long as the treatment helps you and any side effects remain manageable. After finishing the medication, the study team will continue to check on your recovery for at least 30 days, followed by periodic check-ins to monitor your health.
Potential risks and benefits
Locations (4)
- —UnverifiedPortugal
- —UnverifiedBelgium
- —UnverifiedFrance
- —UnverifiedSpain
Common questions
What is a Phase 1/2 trial?
A Phase 1/2 trial is an early-stage study. Phase 1 finds the safest dose and checks for side effects, while Phase 2 tests whether that dose actually works to control or shrink the cancer.
Will I receive a dummy treatment (placebo)?
No. In early cancer trials like this one, every participant receives active cancer treatment. You will not be given an inactive dummy medicine.
Do I have to pay to take part in this study?
No. The trial medicines and study-related tests are provided free of charge, and travel expenses are often reimbursed by the study team.
Can I leave the study if I change my mind?
Yes. Taking part is completely voluntary. You can withdraw your consent and stop participating at any time without giving a reason, and your medical team will continue to care for you.
How will the doctors know if the medicine is working?
The trial team will use regular blood tests and body scans (such as CT or MRI scans) to measure the size of your tumours and monitor your overall health.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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