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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

NCT07498725 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-07-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • LARKSPUR BIOSCIENCES, INC.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-07
Primary Completion
2029-06-30
Completion
2029-06-30

Countries

  • France
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07498725 on ClinicalTrials.gov