Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemo | Drug | Chemotherapy | ALIAS |
| LRK-4189 escalation | Drug | — | UNRESOLVED |
| LRK-4189 expansion | Drug | — | UNRESOLVED |
| LRK-4189 optimization | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part 1/1b escalation
- interventionNames
- Drug: LRK-4189 escalation
- type
- EXPERIMENTAL
- label
- Part 2 expansion
- interventionNames
- Drug: LRK-4189 expansion
- type
- EXPERIMENTAL
- label
- Part 2b expansion
- interventionNames
- Drug: LRK-4189 expansion
- Drug: Chemo
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available