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A Study of IPN60300 in Adults with Locally Advanced or Metastatic Solid Tumors to Assess Safety, Tolerability and Anti-Cancer Activity

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What is this trial about?

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

This study is looking at advanced or metastatic solid tumours, which are cancers that have grown beyond their original location or spread to other parts of the body. The treatment being tested is IPN60300, which is given as a solution for infusion directly into a vein. This means the medication is delivered slowly through a needle placed in a vein, similar to how fluids are given in a hospital setting. The study is divided into different phases, with the first phase testing different doses of the medication to find the safest and most effective amount, and later phases looking at how well the medication works in people with specific types of tumours.

The purpose of the study is to evaluate the safety, tolerability, and how well IPN60300 works against tumours in adults who have received previous treatment that did not work or who have no other standard treatment options available. The study will also look at how the body processes the medication, how it affects the body, and whether the immune system develops a response to it. During the study, participants will receive IPN60300 in cycles that last 21 days each, and their health and tumour response will be monitored regularly through physical examinations, blood tests, and imaging scans to see if the tumours are shrinking, staying the same, or growing.

The study will track various outcomes including any side effects that occur, how many people respond to the treatment with their tumours shrinking or disappearing, and how long these responses last. Participants will be followed throughout their treatment and for a period after their last dose to ensure their safety and to gather complete information about how the medication works. The entire study is expected to last approximately three years, during which participants will have regular visits to assess their condition and response to treatment.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and confirmation of eligibility
Your medical history will be reviewed to confirm that you have locally advanced or metastatic solid tumours (cancer that has spread or cannot be removed by surgery) that have either returned after previous treatment or did not respond to standard treatment.
Your overall health status will be assessed to ensure you can perform daily activities with minimal restrictions (performance status of 0 to 1).
A tumour tissue specimen will be required for laboratory analysis.
Blood tests will be performed within 7 days before receiving the first dose to check your bone marrow function, kidney function, liver function, and blood clotting.
Your life expectancy must be more than 3 months based on your disease.
Step 2
First treatment cycle with IPN60300
You will receive IPN60300, which is an experimental medication given as an infusion into a vein (intravenous infusion).
The first treatment cycle lasts 21 days.
During this cycle, you will be closely monitored for any side effects or complications, particularly for dose limiting toxicity (serious side effects that may require dose adjustment).
Blood samples will be collected at specific times during this cycle to measure the levels of the medication in your blood and understand how your body processes it.
The dosage you receive will depend on which phase of the study you are enrolled in, as the study is designed to find the safest and most effective dose.
Step 3
Second treatment cycle with IPN60300
You will continue receiving IPN60300 as an intravenous infusion.
The second cycle also lasts 21 days.
Blood samples will again be collected during this cycle to continue monitoring how the medication works in your body.
Your health and any side effects will continue to be assessed throughout this cycle.
Step 4
Ongoing treatment cycles
You will continue receiving IPN60300 in repeated cycles.
Each cycle lasts 21 days.
The treatment will continue for as long as your cancer does not progress and you do not experience unacceptable side effects.
Throughout all treatment cycles, any adverse events (unwanted or harmful reactions) and serious adverse events (severe complications requiring medical attention) will be recorded and assessed.
Step 5
Regular tumour assessments
Your tumours will be regularly assessed using imaging scans to determine if they are shrinking, staying the same size, or growing.
These assessments follow standardized criteria called RECIST version 1.1 (Response Evaluation Criteria in Solid Tumours), which provide a consistent way to measure tumour response.
The assessments will measure whether you have a complete response (all tumours have disappeared), partial response (tumours have shrunk significantly), stable disease (tumours have not changed much), or progressive disease (tumours have grown).
Step 6
Monitoring for immune reactions
Blood samples will be collected throughout your participation to check if your immune system is producing antibodies (proteins that your body makes in response to the medication) against IPN60300.
This monitoring will continue from before you receive the study drug until your end of treatment visit.
Step 7
End of treatment visit
When you stop receiving IPN60300, you will have an end of treatment visit.
This visit will occur after your last dose of the medication.
Your overall response to treatment will be evaluated, including how your tumours responded and what side effects you experienced.
Step 8
Follow-up period
After receiving your last dose of IPN60300, you will be monitored for an additional 30 days.
During this period, any continuing or new side effects will be recorded.
The entire study participation may last up to approximately 3 years, depending on how long you continue receiving treatment and how your cancer responds.

Who can join the trial?

13 criteria

You must be 18 years of age or older at the time of signing the consent form
You must have advanced or metastatic solid tumours, which means cancer that has spread beyond its original location or cannot be removed by surgery, confirmed by tissue examination under a microscope
Your cancer must have come back or not responded to previous standard treatments, or there is no standard treatment available for your type of cancer, or standard treatment is not suitable for you as determined by your doctor
Your cancer must be measurable, meaning it can be seen and measured on scans according to specific criteria called RECIST version 1.1
You must have an ECOG performance status of 0 to 1, which is a scale that measures how well you can perform daily activities. A score of 0 means you are fully active, and 1 means you have some restrictions but can still do light work
If you are able to have children, you must agree to use appropriate birth control methods as required by local regulations during the study
Your bone marrow, the tissue inside your bones that makes blood cells, must be working adequately based on blood tests done within 7 days before starting the study treatment
Your kidneys must be working adequately based on blood tests done within 7 days before starting the study treatment
Your liver must be working adequately based on blood tests done within 7 days before starting the study treatment
Your blood clotting time, measured by a test called prothrombin time or INR, must not be more than 1.5 times the upper normal limit
A sample of your tumour tissue must be available at the time of screening for laboratory testing
You must be able to understand and sign the consent form and follow the study requirements
You must have a life expectancy of more than 3 months, as evaluated by your doctor

Who cannot join the trial?

15 criteria

You have a type of cancer that has spread to the brain or the covering of the brain and spinal cord, which means the cancer has moved from its original location to these areas of the nervous system
You have uncontrolled brain cancer, meaning the cancer in your brain is not being managed or controlled by current treatments
You have received certain types of cancer treatments within specific time periods before joining the study, such as chemotherapy, radiation therapy, or other anti-cancer drugs too recently
You have heart problems, including irregular heartbeat, heart attack, chest pain, or heart failure that is not well controlled
You have abnormal heart electrical activity shown on a heart test called an ECG, which measures the rhythm and electrical activity of your heart
You have active infections that require treatment with antibiotics or other infection-fighting medications
You have severe liver problems, meaning your liver is not working properly
You have severe kidney problems, meaning your kidneys are not filtering waste from your blood properly
You have other serious medical conditions that could make it unsafe for you to participate in the study
You are pregnant or breastfeeding, or you are not willing to use effective birth control during the study if you are able to have children
You have a known allergy or severe reaction to the study drug or any of its ingredients
You have received another experimental drug or treatment in a different clinical trial too recently before this study
You have had major surgery too recently before the start of the study
You are unable to swallow pills or absorb medications properly through your digestive system
You have abnormal blood test results that show your bone marrow, liver, or kidneys are not working well enough

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Verified sites

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

Verified
Centre Leon Berard
Lyon, France
Verified
Comite Entreprise Paul Papin
Angers, France
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain

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Investigated drugs

IPN60300 is an investigational medication being studied as a single agent treatment for adults with locally advanced or metastatic solid tumors. This is a first-in-human study, meaning it is the first time this medication is being tested in people. The medication is being evaluated to understand how safe it is, how well it is tolerated by patients, how the body processes it, and whether it has activity against tumors. The study will test different doses to find the most appropriate amount to give to patients.

What is already known about the treatment

IPN60300 – IPN60300 is an experimental cancer treatment currently being studied in early-phase clinical trials for patients with advanced or metastatic solid tumors that have spread or cannot be surgically removed. This medication is administered as a single agent, and researchers are working to determine the safest and most effective dose, as well as how the body processes the drug and how it affects the immune system. The study aims to understand how well IPN60300 works against cancer cells and to identify the best way to use it in patients with specific types of tumors. As an investigational drug, IPN60300 is not yet approved for standard medical use and is only available through participation in this clinical trial.

Investigated diseases

Advanced or Metastatic Solid Tumours – This condition refers to cancerous growths that have either grown extensively in their original location or spread to other parts of the body. Solid tumours are abnormal masses of tissue that form in organs or tissues throughout the body, unlike blood cancers. When described as advanced, the cancer has grown significantly and may be affecting nearby tissues or organs. Metastatic means the cancer cells have traveled from their original site to distant parts of the body through the bloodstream or lymphatic system. These tumours can develop in various organs including the lungs, breast, colon, pancreas, and many other tissues. The disease progresses as cancer cells continue to multiply and spread, potentially affecting multiple organ systems over time.