A Ph 1/2 of PC14586 in Patients with Advanced or Metastatic Tumors w/ TP53 Y220C Mutation - Clinical Trial

What is the Purpose of this Study?

If you decide to participate in this study, you will have a screening visit to see if you meet the criteria to be included in this study. If you are eligible, you will proceed to the study drug period. Durante este período, usted:

  • Take the study drug tablets by mouth at about the same time each morning and within 30 minutes of finishing your breakfast for the first 15 days
  • After the first 15 days, continue to take the study drug by mouth at approximately the same time every day, within 30 minutes of finishing a meal (breakfast, lunch, or dinner) of your choice

Se realizarán las siguientes pruebas y procedimientos a lo largo del estudio:

  • Extracción de sangre
  • Imaging tests (CT, PET/CT and MRI)
  • ECG
What is the Condition Being Studied?

Locally Advanced or Metastatic Solid Tumors with a TP53 Y220C Mutation

Who Can Participate in the Study?

Adults ages 18+ who:

  • Have a confirmed locally advanced or metastatic solid malignancy with a TP53 Y220C mutation
  • Have received prior standard therapy appropriate for their tumor type and stage of disease and have documented progression

Para obtener más información sobre quién puede participar en este estudio, comuníquese con el equipo del estudio al 919-668-6342.

Grupo etario
Adultos

What is Involved?

We are doing this study to find the most effective, safe dose of an experimental drug called PC14586, in people with locally advanced or metastatic solid tumors with a TP53 Y220C mutation.

Study Details

Full Title
A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients with Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
Principal Investigator
Especialista en oncología médica
Protocol Number
IRB: PRO00115807
NCT: NCT04585750
Phase
Phase I/II
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción