A Phase 1 Study of LY5830966 in Participants With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)

This study is looking for adults aged 18 or older who have been diagnosed with a specific type of myelofibrosis (Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis). Your myelofibrosis should be considered moderate to high risk, and your spleen must be enlarged. You also need to be experiencing certain symptoms related to your condition.

Crucially, you must have tried at least one other JAK2 inhibitor drug in the past, but it either didn't work well enough for you, or it stopped working. There are also specific requirements for your blood counts (like white blood cells called ANC, and platelets), kidney function, and liver function to make sure you are healthy enough to take part. Your heart rhythm will also be checked.

However, you won't be able to join if you've had your spleen removed or received radiation to your spleen recently. You also can't be pregnant or breastfeeding. Other reasons you might not be able to participate include having certain uncontrolled infections, specific types of hepatitis, or if you need to take certain medications that might interfere with the study drug.

If you join this study, you will take the study medication, AJ1-11095, by mouth. At first, you will have frequent visits to the study hospital or clinic so the doctors can carefully monitor how you are doing, check for any side effects, and see how your body handles the drug. This will involve blood tests, physical exams, and possibly scans to check your spleen size.

The study will start with a small group of participants and gradually increase the dose of the drug. Once a suitable dose is found, more people might join that dose group. You will continue to have regular check-ups throughout the study to make sure the drug is safe and to see if it is helping with your condition. The total length of your participation will depend on how you respond to the treatment and the study progress, but it will involve ongoing follow-up.