Not yet recruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in Advanced Solid Tumors

This research study, called a Phase 1/2 trial, is investigating a new medication named LCB02A for individuals with advanced solid cancers. These are cancers that have either not improved with standard treatments or for which no standard treatment options are currently available. The study has two main parts: Phase 1 focuses on carefully increasing the dose of LCB02A to find the safest and most effective amount. Once this 'best dose' is identified, Phase 2 will involve giving the drug to more people with specific types of cancer to see how well it works. The drug is designed to target a particular protein found on some cancer cells called Claudin 18.2. Patients will be closely monitored throughout the study to ensure their safety and track any potential benefits.

At a glance

Status

Not yet recruiting

Phase

PHASE1, PHASE2

Sponsor

LigaChem Biosciences, Inc.

Enrolment target

191

Start

01 Aug 2026

Estimated completion

01 Aug 2030

Advanced Solid Tumors

What is this study about?

This study is an important step in developing new treatments for advanced solid cancers. 'Advanced solid tumors' means cancers that have spread or are difficult to treat with current methods. The new drug, LCB02A, is specifically designed to recognise and attack cancer cells that have a particular protein on their surface called Claudin 18.2. Not all cancers have this protein, so a test will be done to see if your cancer does.

This is a 'Phase 1/2' study, which means it has two main goals. In Phase 1, the researchers will start with a very low dose of LCB02A and slowly increase it in small groups of people. This helps them find the safest dose that causes the fewest side effects, but is still likely to be effective. Think of it like carefully finding the right setting on a machine. Once that ‘best dose’ is found, the study moves into Phase 2.

In Phase 2, more patients with specific types of advanced cancers (selected based on early results) will receive this determined dose of LCB02A. The aim here is to see how well the drug works in a larger group – for example, if it helps to shrink tumours or slow their growth. This type of research is crucial because it helps us learn if new treatments like LCB02A could offer hope for people who have run out of other treatment options.

Key takeaways

This study is testing a new cancer drug, LCB02A, for advanced solid cancers.
It targets a specific protein called Claudin 18.2 on cancer cells.
The study aims to find the safest dose and see how well it works.
Participants will receive the active study drug, not a placebo.
It's for people whose cancers haven't responded to standard treatments or who have no other options.

Who may be eligible?

To join this study, your doctor would first need to confirm you have an advanced solid cancer that has Claudin 18.2 protein on its cells. This is important because the drug specifically targets this protein. You would have already tried standard treatments for your cancer, or there are no suitable standard options left for you. The study also needs to see if your cancer can be measured accurately, usually with scans.

You would need to be generally well enough to take part, meaning you can mostly look after yourself. The medical team will check your organ functions, like your blood, liver, and kidneys, with tests to make sure they are working well enough for you to receive the study drug. They might also ask for a sample of your tumour tissue, either from a past procedure or a new small biopsy.

There are also a few reasons you might not be able to join. For example, if you've recently had radiotherapy or if you have certain types of cancer spread to your brain that aren't stable. Also, if you've had a similar type of drug before that included a 'Topo1 inhibitor payload', this study might not be suitable 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.

Do you have an advanced solid cancer that has Claudin 18.2 protein?
Have you already tried standard treatments, or are there no standard options left?
Are you generally well enough to manage daily activities?
Do your blood, liver, and kidney tests show healthy organ function?
Do you not have active, unstable cancer spread to your brain?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive the new drug, LCB02A, which will involve regular visits to the clinic. At these visits, doctors will closely monitor your health, discuss any side effects you might be experiencing, and conduct various tests. These tests typically include blood tests, urine tests, and scans (like CT or MRI) to check how the drug is affecting your cancer and your body.

The frequency of visits will be more often at the beginning of the study and may become less frequent if you continue to tolerate the treatment well. The exact duration of your participation can vary. You will continue to receive the study drug as long as it is working for you and you are not experiencing unacceptable side effects. After you stop receiving the drug, there will be a follow-up period where the study team will continue to check on your health and well-being. The total duration of the study will depend on how you respond to the treatment.

Potential risks and benefits

Participating in this study might offer a potential benefit: you could receive a new treatment that isn't yet widely available, which might help control your cancer if current treatments are no longer effective. However, new drugs always carry potential risks, and LCB02A might cause side effects, some of which could be serious. The medical team will closely monitor you and manage any side effects carefully. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (6)

Dana Farber Cancer Institute
Verified postcode
Boston, United States
Medical University of South Carolina
Verified postcode
Charleston, United States
Princess Margaret Hospital
Verified postcode
Toronto, Canada
Seoul National University Hospital
Verified postcode
Seoul, South Korea
ASAN Medical Center
Verified postcode
Seoul, South Korea
Samsung Medical Center
Verified postcode
Seoul, South Korea

Common questions

What is Claudin 18.2?

Claudin 18.2 is a specific protein that can be found on the surface of some cancer cells. This study drug is designed to specifically target and attack cells that have this protein.

What does 'advanced solid tumors' mean?

It means cancers that have grown or spread to other parts of the body, or cancers that are generally more difficult to treat with standard methods.

What is a Phase 1/2 study?

It's a research study that first finds the safest dose of a new drug (Phase 1) and then tests how well that dose works against cancer in a larger group of people (Phase 2).

Will I get the new drug, or a placebo?

In this study, all participants will receive the active study drug, LCB02A. There is no placebo group in this trial.

What if the drug doesn't work for me?

If the drug isn't working or if you experience severe side effects, your study doctor will discuss stopping the treatment and exploring other options for your care.

How to find out more

David Browning

clinicaltrials@ligachembio.com +1-615-975-7776 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.