Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

A Phase 1/2 Study of Oral LOXO-305 in Patients with Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL)

This research study is investigating a new oral medicine called LOXO-305 for patients who have already received treatment for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL). It’s an early-stage study, meaning it's one of the first times this drug is being tested in humans. The main goals are to find the safest and most effective dose of LOXO-305, either on its own or in combination with other existing treatments. Researchers will also look at how well the drug helps to reduce or control the cancer. They will carefully monitor participants for any side effects and see how the drug behaves in the body.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Loxo Oncology Inc.

Enrolment target

Start

14 Jun 2024

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and Non-Hodgkin Lymphoma (NHL)"

What is this study about?

This study is a clinical trial looking at a new medication called LOXO-305. Clinical trials are how new treatments are tested to see if they are safe and effective before they can be widely used. This particular study is for people who have specific types of blood cancer: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL), and who have already had other treatments.

This trial is in its early stages (Phase 1/2), which means it's among the first times this drug is being given to people. The main aims are to understand how much of the drug can be given safely without causing too many side effects (finding the best dose), and to see if it can help shrink or control the cancer. Researchers will also look at how the drug works in the body and if it improves patients' quality of life. Sometimes, the new drug might be tested on its own, and other times in combination with other established treatments.

Taking part in a study like this can help researchers learn more about new ways to treat cancer, potentially leading to new breakthroughs. It's important to remember that this is a research study, and while the hope is for positive results, there are no guarantees about how the treatment will work for any individual.

Key takeaways

Tests a new oral drug, LOXO-305, for certain blood cancers.
For people with CLL/SLL or NHL who have had previous treatments.
Early stage study (Phase 1/2) to check safety and effectiveness.
Aims to find the best dose and see if cancer shrinks.
You'll have regular hospital visits and health checks.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. Both men and women are welcome to take part.

You would be eligible if you have been diagnosed with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL) and have already received some form of treatment for your condition.

There will be other detailed medical criteria that the study doctors will check to make sure the study is a good fit for you and that it's safe for you to participate.

Quick self-check

Are you 18 years old or older?
Do you have Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)?
Do you have Non-Hodgkin Lymphoma (NHL)?
Have you already received treatment for your cancer condition?
Are you able to take medicine by mouth (orally)?

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

What does participation involve?

If you decide to join this study, you will be taking a new oral medication called LOXO-305. The study team will regularly check your health through blood tests, physical exams, and other medical assessments like ECGs (heart tests). You will have a number of hospital or clinic visits to monitor your progress, check for side effects, and adjust your treatment if needed. You'll discuss with the study team how often these visits will be. The total duration of your participation in the study will vary, but it will involve regular follow-ups for as long as you are receiving the treatment and potentially for some time afterwards to see how you are doing.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new treatment that isn't widely available yet, which could help control your cancer. However, as with any new medicine, there are potential risks, including side effects that may be mild or serious. The research team will explain all known side effects and monitor you closely. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

—
Poland
—
France
—
Italy

Common questions

What is the new drug LOXO-305?

LOXO-305 is an experimental medicine being tested in this study to see if it can treat certain types of blood cancer like CLL/SLL and NHL.

Why is this study called 'Phase 1/2'?

This means it's an early-stage study. Phase 1 focuses on finding a safe dose and understanding side effects. Phase 2 then looks at how well the drug works against the cancer at that safe dose.

Can I join if I've already had treatment for my cancer?

Yes, this study is specifically for patients with CLL/SLL or NHL who have already received previous treatments.

Will I get the new drug or a placebo?

This study does not mention a placebo. Participants will receive LOXO-305, either on its own or in combination with other established treatments.

What kind of tests will I have during the study?

You will have regular blood tests, physical examinations, heart checks (ECGs), and other assessments to monitor your health and the effects of the treatment.