NCT07498725

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: LARKSPUR BIOSCIENCES, INC. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	LRK-4189 escalation	LRK-4189 at various doses
DRUG	LRK-4189 expansion	LRK-4189 MTD
DRUG	LRK-4189 optimization	LRK-4189 2 distinct doses
DRUG	Chemo	Standard of care

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

2 sites across 2 countries: France, United Kingdom