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A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of LRK-4189 Alone and in Combination in Patients With Solid Tumors
Sponsor: LARKSPUR BIOSCIENCES, INC.
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.
Official title: A Phase 1b-2, Open-Label, Dose-Escalation, Expansion and Optimization Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of LRK-4189 Alone and in Combination With mFOLFOX6 or FOLFIRI in Patients With Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-05
Completion Date
2029-06
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
LRK-4189 escalation
LRK-4189 at various doses
LRK-4189 expansion
LRK-4189 MTD
LRK-4189 optimization
LRK-4189 2 distinct doses
Chemo
Standard of care
Locations (2)
Centre Antoine Lacassagne
Nice, France
Western General Hospital
Edinburgh, United Kingdom