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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Centre Jean Perrin	Clermont Ferrand	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
IRCCS Humanitas Research Hospital	Rozzano	Italy
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Asklepios Kliniken Hamburg GmbH	Hamburg	Germany
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Centre Hospitalier Universitaire De Nimes	Nimes	France
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Quironsalud Barcelona	Barcelona	Spain
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Hgomsqjjs Mxvwrbxi Sfsrxl	Milan	Italy
Cdsimk Lbvu Boxlqs	Lyon	France
Uqgiedagffwmyhcqivxqx Ehjpw Aif	Essen	Germany
Ioddic Ixckvrfr Fmcvstogogekv Ogsvlrlzgws	Rome	Italy
Uwlwynyjfhwzxlsxmevls Ablvzrri	Augsburg	Germany
Gogmpg Ugeuaieboy Fcsnfefve	Frankfurt	Germany
Hvcxvtdu Vdas dgwlseej	Barcelona	Spain
Helakbzt Ujovhbeolrpprx Sjywkziwuh &yiqsuu Hrlymrd dd Hvywbhbvdpf	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.05.2024
Germany	Recruiting	01.05.2024
Italy	Recruiting	01.05.2024
Spain	Recruiting	01.05.2024

Trial locations

Investigated drugs:

Pc14586

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.

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 ID:

2023-504251-27-00

Protocol code:

PMV-586-101

NCT ID:

NCT04585750

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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

What is this study about?

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