Study on the Safety and Effects of IPN01195 in Adults with Advanced Solid Tumors

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What is this study about?

This clinical trial is focused on studying a new medicine called IPN01195 for adults with advanced solid tumors. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. These tumors can occur in various parts of the body and are considered advanced when they have spread or are difficult to remove surgically. The purpose of the study is to evaluate the safety and effectiveness of IPN01195 when used alone in treating these tumors.

The study is divided into two parts. In the first part, the focus is on finding a safe and tolerable dose of IPN01195 for participants. This involves gradually increasing the dose to see how the body reacts and to identify the most suitable dose range. In the second part, the study aims to confirm the best dose of IPN01195 for specific types of tumors. Participants will take the medicine in the form of a coated tablet, which is taken orally, meaning it is swallowed.

Throughout the study, researchers will monitor participants for any side effects and measure how the medicine is processed in the body. They will also assess the medicine’s ability to shrink or control the tumors. The study will help determine if IPN01195 can be a potential treatment option for people with advanced solid tumors. The trial is expected to continue for several years to gather comprehensive data on the medicine’s effects.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose, procedures, and potential risks and benefits. You will be required to sign an informed consent form, which confirms your understanding and agreement to participate in the study.

2 initial screening

You will undergo an initial screening to confirm eligibility. This includes providing a sample of your tumor tissue, either from previous tests or a new biopsy, to check for specific genetic changes.

Your overall health and performance status will be assessed to ensure you meet the study’s requirements.

3 part a: dose escalation

In this phase, you will receive the study medication, IPN01195, in the form of a coated tablet taken orally. The dose may be adjusted to find the most suitable level for safety and effectiveness.

You will be monitored closely for any side effects or reactions to the medication. This phase lasts up to 28 days from the first dose.

4 part b: dose confirmation

Once the optimal dose is identified, you will continue to receive IPN01195 at this dose. The goal is to confirm its effectiveness in treating your specific type of tumor.

Regular assessments will be conducted to evaluate your response to the treatment and monitor for any adverse effects.

5 ongoing monitoring

Throughout the study, you will have regular check-ups to monitor your health and the progress of your treatment. This includes blood tests, imaging scans, and other necessary evaluations.

You will be asked to report any new symptoms or changes in your condition to the study team.

6 end of study

The study will conclude after a specified period, or if you choose to withdraw or if the study team decides it is in your best interest to stop.

A final assessment will be conducted to evaluate the overall impact of the treatment on your condition.

Who Can Join the Study?

Participants must be at least 18 years old or the legal age of majority in their country if it is higher than 18.
Participants must have a confirmed diagnosis of an advanced or unresectable or recurrent solid tumor. This means the tumor is either advanced, cannot be removed by surgery, or has come back after treatment.
Participants must have tried standard treatments that did not work, could not tolerate them, or there are no standard treatments available to improve their condition.
Participants must have tumors with specific genetic changes in the MAPK pathway, which will be confirmed by a special test done in a certified lab.
For Part A: Participants must agree to use stored tumor tissue or, if not available, provide a new tumor sample for testing to confirm mutation status.
For Part B: Participants must agree to use stored tumor tissue or, if not available, provide a new tumor sample for MAPK genomic testing to confirm eligibility.
Participants must have a disease that can be measured according to specific criteria called RECIST version 1.1.
Participants must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest during the day.
Participants must use contraception methods that comply with local regulations if they are able to have children.
Participants must be able to give signed informed consent, which means they understand and agree to follow the study requirements and restrictions.

Who Cannot Join the Study?

Patients with any other serious medical condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with known allergies to the study medication or its ingredients.
Patients who are unable to comply with the study procedures.
Patients with a history of substance abuse that could affect their ability to participate in the study.
Patients with certain heart conditions that could pose a risk during the study.
Patients with uncontrolled infections.
Patients with a history of certain types of cancer that are not the focus of this study.
Patients who are taking medications that might interfere with the study drug.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
MD Anderson Cancer Center	Madrid	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Cjxyfk Lhnb Baiefm	Lyon	France
Atywrphobn Pptqkveu Hpgcyhow Ds Pihgd	Paris	France
Hdmogmld Vnqw dszxvrom	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Recruiting	30.05.2025
Italy	Recruiting	30.05.2025
Spain	Recruiting	30.05.2025

Trial locations

Investigated drugs:

IPN01195

IPN01195 is a new medication being tested in this clinical trial. It is designed to be used by itself to treat adults with advanced solid tumors. The main goal of the trial is to find out how safe and tolerable this medication is for patients, and to determine the best dose that can be given without causing too many side effects. Researchers are also looking to see how the body processes the medication and how it affects the tumors. This study is important because it helps to understand if IPN01195 can be an effective treatment option for people with certain types of cancer.

Investigated diseases:

Neoplasm

Advanced Solid Tumor – Advanced solid tumors are a group of cancers that originate in solid organs or tissues, such as the breast, lung, or colon, and have progressed to a more severe stage. These tumors are characterized by their ability to grow uncontrollably and invade nearby tissues. As they advance, they may spread to other parts of the body, a process known as metastasis. The progression of these tumors can lead to the disruption of normal organ function. Symptoms vary depending on the tumor’s location and size, and may include pain, swelling, or organ dysfunction. The disease’s progression is often monitored through imaging and other assessments to evaluate changes in tumor size and spread.

Trial ID:

2024-519184-18-00

Protocol code:

CLIN-01195-450

NCT ID:

NCT06833008

Trial Phase:

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

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Study on the Safety and Effects of IPN01195 in Adults with Advanced Solid Tumors

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