LRK-4189: a first look at safety and early effectiveness in solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-phase interventional trial to evaluate LRK-4189 in adults with solid tumors. Participants may receive LRK-4189 by itself or combined with standard chemotherapy, with daily dosing for up to three years. Regular weekly clinic visits will monitor safety, tolerability, and preliminary signs of efficacy, including tumor measurements. The study also explores different LRK-4189 dosing strategies across escalation, expansion, and optimization cohorts. Eligibility requires measurable disease, ECOG 0-1, biopsy willingness, normal ECG, stable lab results, and reproductive considerations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Willing and able to sign the study consent form and take part in all required study visits, tests, and procedures.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Have a locally advanced or metastatic cancer that cannot be removed with surgery and has gotten worse despite treatment.
* Cancer can be measured on scans, such as CT or MRI.
* Willing to have tumor biopsies, meaning small samples of your tumor will be collected during the study.
* Heart rhythm test (ECG) shows a normal result within safe limits.
* Blood test results at screening are within an acceptable and stable range.
* If you are a woman, you are not able to become pregnant, or you agree not to become pregnant during the study and to use approved birth control methods.
* If you are a man, you agree not to donate sperm during the study. If you have sex with a partner who could become pregnant, you agree to use approved birth control methods during the study.

Exclusion Criteria:

* Unable to swallow the study medication or your body cannot absorb it.
* Have had a serious allergic reaction to LRK-4189 or any of its ingredients.
* Have needed a fluid drainage procedure from the chest or abdomen within the past 6 weeks.
* Have active cancer in the brain or spinal fluid, or brain tumors that require steroid treatment.
* Currently receiving another cancer treatment.
* Have an active HIV, hepatitis B, or hepatitis C infection with detectable virus levels.
* Have an active infection that requires treatment through a vein (IV).
* Taking certain medications that strongly interact with the study drug and cannot stop them at least 14 days before starting the study.
* Pregnant or breastfeeding or planning to become pregnant or father a child during the study.
* Cannot safely receive the standard chemotherapy that would be used with this study.

Where it's running

• Centre Antoine Lacassagne
  Nice, France Recruiting
• Hopitaux Universitaires de Strasbourg
  Strasbourg, France Recruiting
• Western General Hospital
  Edinburgh, United Kingdom Recruiting

Study contacts

• Study coordinator: Ceo
• Email: trialinfo@larkspur.bio
• Phone: 6176931232

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.