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Clinical Trial NCT07498725 for Neoplasms is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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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 Phase 1, Phase 2 120

Not yet recruiting
Clinical Trial NCT07498725 is designed to study Treatment for Neoplasms. This Phase 1 Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 1 May 2026 until the study accrues 120 participants. Led by LARKSPUR BIOSCIENCES, INC., this study is expected to complete by 1 June 2029. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.
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 inves...
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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

Conditions
Neoplasms
Other Study IDs
  • LRK-4189-102
NCT ID Number
NCT07498725
Start Date (Actual)
2026-05
Last Update Posted
2026-03-27
Completion Date (Estimated)
2029-06
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
Phase 1
Phase 2
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPart 1/1b escalation
LRK-4189 escalation
LRK-4189 at various doses
ExperimentalPart 2 expansion
LRK-4189 expansion
LRK-4189 MTD
ExperimentalPart 2b expansion
LRK-4189 expansion
LRK-4189 MTD
Chemo
Standard of care
ExperimentalPart 3 optimization
LRK-4189 optimization
LRK-4189 2 distinct doses
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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.
LARKSPUR BIOSCIENCES, INC. logoLARKSPUR BIOSCIENCES, INC.
Study Central Contact
Contact: CEO, 6176931232, [email protected]
2 Study Locations in 2 Countries
Centre Antoine Lacassagne, Nice, France
Sr. Director, Program Management, Contact, 6176931232, [email protected]
Western General Hospital, Edinburgh, United Kingdom
Sr. Director, Program Management, Contact, 6176931232, [email protected]