NCT07498725 A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of LRK-4189 Alone and in Combination in Patients With Solid Tumors
| NCT ID | NCT07498725 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | LARKSPUR BIOSCIENCES, INC. |
| Condition | Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-07-07 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 120 participants in total. It began in 2026-07-07 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if investigational agent LRK-4189 works to treat solid tumors in adults, with a focus on colorectal cancer. It will also learn about the safety of drug LRK-4189. The main questions it aims to answer are: Is LRK-4189, administered alone or in combination with standard chemotherapy regimens, safe and tolerable in patients with solid tumors? Participants will: * Take investigational agent LRK-4189 alone or in combination with standard chemotherapy regimens every day for up to 3 years. * Visit the clinic once every week for checkups and tests.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07498725 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07498725 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07498725 currently recruiting?
Yes, NCT07498725 is actively recruiting participants. Contact the research team at trialinfo@larkspur.bio for enrollment information.
Where is the NCT07498725 trial being conducted?
This trial is being conducted at Nice, France, Strasbourg, France, Edinburgh, United Kingdom.
Who is sponsoring the NCT07498725 clinical trial?
NCT07498725 is sponsored by LARKSPUR BIOSCIENCES, INC.. The trial plans to enroll 120 participants.