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El ensayo clínico NCT07498725 para Neoplasias está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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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 Fase I, Fase II 120

Aún no recluta
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07498725 está diseñado para estudiar el tratamiento de Neoplasias. Este es un estudio intervencionista de Fase I Fase II. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de mayo de 2026 hasta completar 120 participantes. Dirigido por LARKSPUR BIOSCIENCES, INC., se espera que finalice el 1 de junio de 2029. Los datos se actualizaron por última vez en ClinicalTrials.gov el 27 de marzo de 2026.
Resumen

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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Título oficial

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

Condiciones médicas
Neoplasias
Otros ID del estudio
  • LRK-4189-102
Número del NCT
NCT07498725
Inicio del estudio (real)
2026-05
Última actualización
2026-03-27
Fecha de finalización (estimada)
2029-06
Inscripción (prevista)
120
Tipo de estudio
Intervencionista
FASE
Fase I
Fase II
Estado general
Aún no recluta
Objetivo principal
Tratamiento
Método de asignación
No aleatorizado
Modelo de intervención
Diseño secuencial
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
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
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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)
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  • 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.
Contactos centrales del estudio
Contacto: CEO, 6176931232, [email protected]
2 Centros del estudio en 2 países
Centre Antoine Lacassagne, Nice, France
Sr. Director, Program Management, Contacto, 6176931232, [email protected]
Western General Hospital, Edinburgh, United Kingdom
Sr. Director, Program Management, Contacto, 6176931232, [email protected]