Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Dose Escalation and Cohort Expansion Study of KB-0742 in Participants With Relapsed or Refractory Solid Tumors or Non-Hodgkin Lymphoma.

This research study is testing a new drug, KB-0742, in people who have solid tumours (cancers that form lumps) or a type of lymphoma called Non-Hodgkin Lymphoma. These cancers must have either returned after treatment or not responded to previous treatments. It's an early-stage study (Phase 1), which means it's one of the first times this drug is being given to people. The main goals are to find out if the drug is safe, what the right dose should be, and how it affects the body. Researchers will be observing participants closely to understand more about this new treatment.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Kronos Bio Inc.

Enrolment target

Start

17 Nov 2023

Relapsed or refractory solid tumors or non-Hodgkin lymphoma

What is this study about?

This study is exploring a new treatment called KB-0742 for people living with certain types of cancer. Specifically, it's for solid tumours – which are cancers that form a mass or lump in the body – or for Non-Hodgkin Lymphoma, a type of cancer that starts in white blood cells called lymphocytes. The study is particularly looking for individuals whose cancer has either come back after being treated before (we call this 'relapsed') or hasn't responded to standard treatments (known as 'refractory').

This is a 'Phase 1' study, which means it's an early step in testing a new medication. The very first time a new drug is given to people, it's called 'first administration to humans'. In this phase, doctors are primarily focused on safety. They want to understand if the drug is safe to use in people, what potential side effects it might have, and what the best dose is to give. They'll also start to get an idea of how the drug works in the body.

The information gathered in studies like this is really important. It helps doctors decide if a new treatment is promising enough to continue testing in larger studies. The aim is always to find new and more effective ways to treat conditions like cancer, especially when current treatments aren't working as well as hoped.

Key takeaways

This study is for a new drug called KB-0742.
It's for specific types of cancer that have returned or not responded to other treatments.
It's an early-stage study primarily focused on safety and finding the best dose.
Participants must be 18 years old or older.
You will receive the new study medication if you take part.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. There is no upper age limit, meaning people of any adult age can potentially take part.

This study is for people who have been diagnosed with certain types of cancer. Specifically, you must have a 'solid tumour' (a cancer that forms a lump) or a type of blood cancer called 'Non-Hodgkin Lymphoma'.

Another important requirement is that your cancer must be 'relapsed' – meaning it has come back after you've had treatment before – or 'refractory', which means it hasn't responded to the treatments you've already received.

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.

Are you 18 years old or older?
Do you have a solid tumour or Non-Hodgkin Lymphoma?
Has your cancer come back after treatment or not responded to previous treatments?

Answer every question to see your result.

What does participation involve?

As this is an early-stage study, taking part will involve regular visits to the clinic for check-ups and assessments. These visits are important for the medical team to monitor your health closely, see how the new medication is affecting you, and look for any potential side effects. You will receive the study medication, KB-0742, throughout your participation. The team will perform various tests, such as blood tests and scans, to understand how your body is responding to the treatment. The total duration of your participation, including follow-up appointments, will be clearly explained by the study team.

Potential risks and benefits

Participating in any clinical trial involves potential benefits and risks. A potential benefit of this study is that you might be among the first to receive a new treatment that could help with your cancer, especially if other treatments haven't worked. However, because this is a new drug, all the potential side effects are not yet fully known, and there might be risks. The study team will explain all known potential risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Spain
—
Unverified
France

Common questions

What is a 'solid tumour'?

A solid tumour is a type of cancer that forms a mass or lump, unlike blood cancers like leukaemia.

What does 'relapsed or refractory' mean?

It means your cancer has either come back after previous treatment (relapsed) or it hasn't responded to treatments you've already had (refractory).

What is a Phase 1 study?

A Phase 1 study is an early stage of testing a new drug in humans. Its main goal is to check for safety, find the right dose, and see how the body reacts to the medication.

Will I get the new drug KB-0742?

Yes, if you join this study, you will receive the new medication called KB-0742.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason. Your decision will not affect your future medical care.