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NOT YET RECRUITING
NCT07498725
PHASE1/PHASE2

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.

View on ClinicalTrials.gov

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

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

Locations (2)

Centre Antoine Lacassagne

Nice, France

Western General Hospital

Edinburgh, United Kingdom