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

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

Overview

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.

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

Primary outcome measures

• Evaluation of treatment-related adverse events and/or toxicity, presented by dose, regimen and tumor type [Time frame: From enrollment to the end of the first treatment cycle (each cycle is 21 days)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

France · 2 centers

• Centre Antoine Lacassagne — Nice
• Hopitaux Universitaires de Strasbourg — Strasbourg

United Kingdom · 1 center

• Western General Hospital — Edinburgh

Identifiers

NCT: NCT07498725 · LRK-4189-102

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗