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

NCT07498725 | Not Yet Recruiting Phase 1

• 1 other identifier: LRK-4189-102
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 2

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• Evaluation of treatment-related adverse events and/or toxicity, presented by dose, regimen and tumor type

  From enrollment to the end of the first treatment cycle (each cycle is 21 days)

Study Arms (4)

Part 1/1b escalation

EXPERIMENTAL

Drug: LRK-4189 escalation

Part 2 expansion

EXPERIMENTAL

Drug: LRK-4189 expansion

Part 2b expansion

EXPERIMENTAL

Drug: LRK-4189 expansion; Drug: Chemo

Part 3 optimization

EXPERIMENTAL

Drug: LRK-4189 optimization

Interventions

LRK-4189 escalation DRUG

LRK-4189 at various doses

Part 1/1b escalation

LRK-4189 expansion DRUG

LRK-4189 MTD

Part 2 expansion; Part 2b expansion

LRK-4189 optimization DRUG

LRK-4189 2 distinct doses

Part 3 optimization

Chemo DRUG

Standard of care

Part 2b expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LARKSPUR BIOSCIENCES, INC.: lead

Study Sites (2)

Centre Antoine Lacassagne

Nice, France

Location

Western General Hospital

Edinburgh, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

CEO

CONTACT

6176931232; trialinfo@larkspur.bio

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

FR (1); GB (1)