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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)

What is this study?

This study is testing a new experimental drug called rezatapopt, designed to target cancers that have a specific genetic change known as the TP53 Y220C mutation. By focusing on this specific mutation, researchers hope to find a more effective way to treat advanced cancers that have not responded well to previous therapies.

Who can participate?

This trial is for adults (and some teenagers with special approval) who have advanced or spread solid tumors that carry the TP53 Y220C mutation. To participate, you must be in good enough health to carry out daily activities and have already tried at least one other cancer treatment that did not stop your cancer from growing.

What will happen?

Participants will receive the study drug, rezatapopt, either alone or in combination with an immunotherapy drug called pembrolizumab, which helps your immune system fight the cancer. The doctors will closely monitor your safety, how your body handles the medicine, and how well the treatment works against your cancer.

Where and when?

The study is currently recruiting patients at medical centers in Irvine, La Jolla, and Los Angeles, California. Please talk to your oncologist to see if this trial might be a good option for your specific situation.

Key Points
  • 1Targeted treatment for cancers with the specific TP53 Y220C genetic mutation.
  • 2Evaluating both a new experimental drug and a combination with existing immunotherapy.
  • 3Available for various types of advanced solid tumors that have not responded to prior care.

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Conditions Studied
This study is investigating treatments for the following conditions
Advanced Solid TumorAdvanced Malignant NeoplasmMetastatic CancerMetastatic Solid TumorLung CancerOvarian CancerEndometrial CancerProstate CancerColorectal CancerBreast CancerOther CancerLocally AdvancedHead and Neck CancerGall Bladder CancerSmall Cell Lung CancerSmall Cell Lung Cancer ( SCLC )Small Cell Lung CarcinomaNSCLCNSCLC (Non-small Cell Lung Cancer)SCLCNon-Small Cell Lung CarcinomaTriple Negative Breast CancerTNBCHER2+ Breast CancerNon-Small Cell Lung CancerER/PR Positive Breast CancerHER2- Breast CancerHER2-positive Breast CancerHER2-negative Breast CancerER/PR(+), Her2(-) Breast Cancer

This summary was generated using AI and may not capture all details. Always consult with a healthcare professional for medical advice.