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Study of PC14586 for Patients with Advanced Solid Tumors with a Specific TP53 Mutation

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as solid tumors that have a specific genetic change called the TP53 Y220C mutation. These tumors can be either locally advanced, meaning they have grown significantly but are still in the area where they started, or metastatic, meaning they have spread to other parts of the body. The treatment being tested in this study is a new medication called PC14586, which is taken as a film-coated tablet by mouth.

The purpose of the study is to evaluate how well PC14586 works in treating these specific types of tumors. Participants in the study will receive the medication and be monitored for its effects on their cancer. The study will also look at how safe and tolerable the medication is for patients, as well as how the body processes the drug. This will involve regular check-ups and assessments by healthcare professionals to ensure the well-being of the participants.

Throughout the study, participants will undergo various tests and evaluations to track the progress of their treatment. These may include imaging tests to see how the tumors respond to the medication and regular health assessments to monitor any side effects. The study aims to gather important information that could lead to new treatment options for patients with these specific types of cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    A tumor biopsy may be required if previous samples are not available. This is to confirm the presence of a TP53 Y220C mutation, which is necessary for participation.

  2. Step 2

    Treatment initiation

    The treatment involves taking a medication called PC14586, which is provided in the form of a film-coated tablet.

    The medication is taken orally. The specific dosage and frequency will be determined by the study team based on individual needs and responses.

  3. Step 3

    Ongoing monitoring

    Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes physical exams, blood tests, and imaging studies.

    The study team will evaluate the response to the treatment using specific criteria to measure any changes in the tumor.

  4. Step 4

    Follow-up assessments

    Throughout the study, follow-up assessments are scheduled to monitor health status and any side effects experienced.

    These assessments help in understanding the long-term effects of the treatment and in making necessary adjustments.

  5. Step 5

    Completion of study

    Upon completion of the study, a final assessment is conducted to evaluate the overall response to the treatment.

    Participants may be asked to continue follow-up visits to monitor any lasting effects of the treatment.

Who can join the trial?

14 criteria

  • The patient must be at least 18 years old.
  • The patient must understand the study procedures and agree to participate by signing a consent form.
  • The patient must have an **ECOG status** of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • The patient must have a confirmed **locally advanced or metastatic solid tumor** with a specific **TP53 Y220C mutation** found through a special test.
  • The patient must have received standard treatment for their type of cancer and have shown disease progression, or they must be considered ineligible for standard treatment by the doctor.
  • For patients with **ovarian cancer**, the disease must have progressed within 6 months of platinum-based chemotherapy or during the therapy.
  • Patients with **CRPC** (a type of prostate cancer) must be receiving ongoing hormone therapy or have had a procedure to lower testosterone levels.
  • The patient must have adequate organ function, which includes specific levels for liver, kidney, and bone marrow health.
  • Female patients who can have children must have a negative pregnancy test before starting the study or be unable to have children due to menopause or surgery.
  • Female patients who can have children must use a highly effective method of birth control or choose to abstain from heterosexual intercourse during the study.
  • Male patients must either abstain from heterosexual intercourse or use a condom with a female partner who can have children, along with another effective birth control method, during the study and for 3 months after the last dose. They must also not donate sperm during this time.
  • The patient must be willing to have a **tumor biopsy** if a previous sample is not available and if it is safe to do so.
  • The patient must have a life expectancy of at least 3 months as determined by the doctor.
  • The patient must have measurable disease according to specific criteria, with the last imaging done within 28 days before starting the study.

Who cannot join the trial?

5 criteria

  • Patients who do not have a specific type of genetic change in their tumor called a TP53 Y220C mutation cannot participate. This mutation is a change in the DNA of the tumor that affects how it grows.
  • Patients with tumors that are not considered locally advanced or metastatic are excluded. Locally advanced means the tumor has grown but not spread far, while metastatic means the cancer has spread to other parts of the body.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, may not be eligible.
  • Patients who do not meet other specific health criteria set by the study may also be excluded.
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Investigated drugs

PC14586 is an investigational medication being studied for its potential to treat patients with advanced or metastatic solid tumors that have a specific genetic mutation known as TP53 Y220C. This medication is being tested to see how safe and tolerable it is for patients, as well as how it behaves in the body and its effectiveness in treating the tumors.

What is already known about the treatment

PC14586 – This medication is administered orally and is currently being studied in clinical trials for its potential use in treating locally advanced or metastatic solid tumors with a specific genetic mutation known as TP53 Y220C. It is in the investigational stage, meaning it is not yet approved for general medical use but is being evaluated for safety and effectiveness. The main therapeutic indication is for cancers that have this particular mutation, which is a change in the TP53 gene that can affect tumor growth. PC14586 works by targeting and stabilizing the mutated form of the p53 protein, which is involved in controlling cell division and preventing tumor development. It is classified as an investigational anti-cancer agent.

Investigated diseases

Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation – This condition involves solid tumors that have either spread locally or to other parts of the body and contain a specific genetic mutation known as TP53 Y220C. The TP53 gene is crucial for regulating cell growth and preventing cancer, and mutations in this gene can lead to uncontrolled cell division. Tumors with this mutation can occur in various organs and are often more aggressive due to the loss of normal TP53 function. The progression of these tumors can vary depending on the location and type of the tumor, as well as the presence of other genetic changes. The mutation can make these tumors resistant to certain treatments, contributing to their progression. Understanding the specific mutation helps in tailoring potential therapeutic approaches.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-504251-27-00Protocol codePMV-586-101Estimated enrolment165 patientsSponsorPmv Pharmaceuticals Inc.

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