Not yet recruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of LRK-4189 Alone and in Combination in Patients With Solid Tumors

This research is looking into a new medicine, LRK-4189, for adults who have solid tumours (cancers) that have grown or spread. The study, involving both early and later stages of testing, wants to find out if LRK-4189 is safe to use and how well it works to treat these cancers, particularly bowel cancer. Participants will take LRK-4189 every day, either by itself or alongside standard chemotherapy treatments, for up to three years. They will also attend weekly clinic appointments for health checks and tests. The study will help doctors understand if LRK-4189 can be a useful new treatment option for people with advanced cancer.

At a glance

Status

Not yet recruiting

Phase

PHASE1, PHASE2

Sponsor

LARKSPUR BIOSCIENCES, INC.

Enrolment target

120

Start

01 May 2026

Estimated completion

01 Jun 2029

Neoplasms

What is this study about?

This research study is about a new medicine called LRK-4189, which is being investigated as a treatment for different types of solid tumours in adults. Solid tumours are cancers that form a lump, rather than being in the blood, like leukaemia. The main goals of this study are to carefully check if LRK-4189 is safe for people to take, and also to get an early idea of how well it might work against cancer. The study is particularly interested in bowel (colorectal) cancer, but it's open to people with other solid tumours too.

Researchers want to see how LRK-4189 works both on its own and when given together with standard chemotherapy treatments that are already used for cancer. By doing this, they hope to find out if combining LRK-4189 with existing treatments could be more effective. Finding new and safer ways to treat cancer is always the main aim of these types of studies.

This study is happening in two stages (Phase 1 and Phase 2). The first stage is usually about finding the right dose and checking for side effects, while the second stage looks more closely at how well the treatment works. The information gathered from this study will help doctors understand if LRK-4189 has the potential to become a new treatment option for people whose cancer has already been treated with other methods but has grown or spread.

Key takeaways

It's about a new medicine (LRK-4189) for advanced solid tumours, especially bowel cancer.
The study checks for safety and how well the medicine works.
You might take LRK-4189 alone or with standard chemotherapy.
Participation involves regular clinic visits and tests, sometimes including tumour samples.
It's for adults whose cancer has grown or spread despite previous treatments.
You can stop participating at any time.

Who may be eligible?

To join this study, your doctor will need to check if you meet certain requirements. Generally, you should be an adult aged 18 or over. You must have a solid tumour that has either grown locally (spread nearby) or to other parts of your body, and which hasn't responded well to previous treatments. Your cancer must also be able to be measured on scans, and you should be generally well enough to take part, meaning you can walk around and look after yourself for most of the day.

Some things might mean this study isn't right for you. For example, if you can't swallow medicines, have had a serious allergy to similar drugs, or have active cancer in your brain or spine that needs steroid treatment. You also can't be taking part in another cancer treatment study at the same time, or have certain active infections like HIV or hepatitis that are not under control. People who are pregnant or breastfeeding, or planning to become pregnant, cannot join.

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 that has grown or spread after other treatments?
Can your cancer be measured on scans like CT or MRI?
Are you generally well enough to do most daily activities?
Are you willing to have small tumour samples (biopsies) taken during the study?
Are you not currently pregnant or breastfeeding, and not planning to become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will take the study medicine, LRK-4189, every day. Depending on the study group you are in, you might take it by itself or along with standard chemotherapy, which your doctor will explain. This treatment period could last for up to three years.

Throughout the study, you will need to visit the clinic regularly. In the beginning, these visits will be once a week for check-ups and tests. These tests help the study team monitor your health, see how your body is reacting to the medicine, and check any changes in your cancer. The team will also monitor for any side effects. You will also have small samples of your tumour taken (called biopsies) at certain times during the study.

Potential risks and benefits

Taking part in any medical study has both potential benefits and potential risks. You might find that the new medicine LRK-4189 helps to control your cancer, or even shrink your tumour, especially if other treatments haven't worked well. However, it's also possible that LRK-4189 won't help your cancer, or that you might experience side effects. The research team will carefully monitor you for any reactions to the medicine. You will be given detailed information about all known risks and benefits before you decide to join. Remember, taking part is completely voluntary, and 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.

Centre Antoine Lacassagne
Verified postcode
Nice, France
Western General Hospital
Verified postcode
Edinburgh, United Kingdom

Common questions

What type of cancer is this study for?

This study is mainly for adults with various solid tumours that have grown or spread, with a special focus on bowel (colorectal) cancer.

What is LRK-4189?

LRK-4189 is a new medicine being tested to see if it can help treat cancer. It is not yet approved for general use.

How long will I take the medicine?

You could be taking the study medicine, LRK-4189, for up to three years, depending on how your treatment progresses and if you wish to continue.

Will I get standard chemotherapy as well?

Some people in the study will take LRK-4189 on its own, and others will take it alongside standard chemotherapy treatments.

What happens if I want to stop taking part?

You are free to leave the study at any time, for any reason, without it affecting your ongoing healthcare or relationship with your medical team.

How to find out more

CEO

trialinfo@larkspur.bio 6176931232 Official trial record

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