Not recruiting

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

Verified siteInvestigational

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

10 criteria

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 trial?

10 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Paris
Paris, France
Verified
Centre Leon Berard
Lyon, France
Verified
Fondazione I.R.C.C.S. Istituto Neurologico Besta
Milan, Italy

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

IPN01195

What is already known about the treatment

IPN01195 – IPN01195 is administered orally in the form of a pill and is currently being studied in clinical trials for its potential use in treating advanced solid tumors. This medication is in the early stages of research, specifically in a phase I/II trial, which means it is being tested for safety, tolerability, and effectiveness in humans for the first time. The main therapeutic indication for IPN01195 is advanced solid tumors, which are cancers that form in the tissues of the body. At the molecular level, IPN01195 works by targeting specific pathways in cancer cells to inhibit their growth and spread, although the exact mechanism is still under investigation. It is classified pharmacologically as an investigational anti-cancer agent.

Investigated diseases

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.