A Study of IPN01203 for Adults With Advanced or Metastatic Solid Tumors After Immune Checkpoint Inhibitor Treatment

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What is this study about?

This study involves people with advanced solid tumors or metastatic solid tumors, which are cancers that have spread to other parts of the body or have grown to an advanced stage. These participants have previously received treatment with immune checkpoint inhibitor therapies, which are medications designed to help the immune system fight cancer, but their disease has continued to grow despite this treatment. The study will use an experimental medication called IPN01203, which is given as a solution for infusion through a vein. This medication is being tested for the first time in humans to see how it works in treating these types of cancers.

The purpose of this study is to evaluate the safety and tolerability of IPN01203, to determine the appropriate dose that can be given safely, and to assess whether the medication has any effect in fighting cancer. The study will also examine how the body processes the medication, how it affects the body, and whether the immune system develops antibodies against it. Additionally, researchers want to find out the best way to give this medication to people with these types of tumors.

The study is divided into different phases. In the first phase, different doses of IPN01203 will be tested to find the highest dose that can be given safely without causing serious side effects. In the next phase, the researchers will work to determine the best dosing schedule for the medication. Throughout the study, participants will be monitored for any side effects and their tumors will be measured using scans such as CT or MRI to see if the treatment is having any effect on the cancer. Blood tests and other assessments will be done regularly to check how the medication is working and how the body is responding to it.

1 Initial assessment and confirmation of eligibility

Your medical condition will be assessed to confirm that you have locally advanced or metastatic solid tumours (cancer that has spread or cannot be removed by surgery).

Your disease will be measured using imaging scans such as CT (computed tomography) or MRI (magnetic resonance imaging) to ensure there is at least one tumour that can be measured.

Your general health status will be evaluated using the ECOG performance status, which is a scale from 0 to 5 that measures how the disease affects your daily living abilities. You must have a score of 0 to 1, meaning you are fully active or restricted in physically strenuous activity but able to carry out light work.

Blood tests and other examinations will be performed to check that your blood counts and organ functions (such as liver and kidneys) are adequate.

Any side effects from previous cancer treatments must have improved to a mild level before you can begin this study.

2 Beginning treatment with IPN01203

You will receive IPN01203, which is an experimental medication being tested in this study.

The medication will be given as an intravenous infusion (through a vein in your arm or hand).

The study is divided into two phases: Phase Ia and Phase Ib.

In Phase Ia, the main goal is to find the safest dose of IPN01203 by gradually increasing the dose in different groups of participants. The study will determine the maximum tolerated dose (the highest dose that does not cause unacceptable side effects) or the maximum administered dose.

In Phase Ib, the study will determine the best dosing schedule for IPN01203.

3 Regular monitoring during treatment

Throughout the study, you will be monitored closely for any side effects or adverse reactions to the treatment.

Blood samples will be taken at specific times to measure the levels of IPN01203 in your blood. This helps determine how your body processes the medication, including how quickly it reaches its highest level (Cmax), when it reaches that level (Tmax), and how long it stays in your body (AUCtau).

Your blood will also be tested to see if your immune system produces antibodies against IPN01203, which could affect how the medication works.

Regular imaging scans (CT or MRI) will be performed to measure your tumours and assess how the cancer is responding to treatment. These measurements follow a standard system called RECIST version 1.1, which provides consistent criteria for evaluating tumour size changes.

4 Assessment of treatment response

Your doctors will evaluate how your cancer responds to IPN01203 by looking at changes in tumour size on imaging scans.

Possible responses include: complete response (all tumours disappear), partial response (tumours shrink by a certain amount), stable disease (tumours neither grow nor shrink significantly), or progressive disease (tumours grow or new tumours appear).

The time it takes for your tumours to respond to treatment will be recorded.

If your tumours respond to treatment, the duration of that response will be measured until the disease progresses or other changes occur.

If your disease remains stable, this period will be measured, with a minimum duration of 8 weeks required to be considered stable disease.

5 Continuation of treatment and long-term follow-up

You will continue receiving IPN01203 according to the dosing schedule determined for your group in the study.

The study will track how long you remain without disease progression (progression-free survival), which is the time from when you start treatment until your disease worsens or other events occur.

Your overall disease control will be assessed, which includes complete response, partial response, or stable disease.

You will continue to be monitored for side effects throughout your participation in the study.

The study is expected to continue until 2032, though your individual participation length will depend on how you respond to treatment and whether you experience any unacceptable side effects.

Who Can Join the Study?

  • You must be 18 years of age or older at the time you sign the consent form to join the study
  • You must have an ECOG performance status of 0 to 1, which is a score that measures how the disease affects your daily living abilities, where 0 means you are fully active and 1 means you have some restrictions but can still do light work
  • You must have measurable disease, meaning at least one tumor that can be measured using imaging scans like CT (a special type of X-ray that creates detailed pictures of the inside of your body) or MRI (a scan that uses magnets and radio waves to create pictures of your organs)
  • Your cancer must be locally advanced (has grown beyond where it started but has not spread to distant parts of the body) or metastatic (has spread to other parts of the body)
  • Any side effects from previous cancer treatments must have improved to mild levels or resolved completely before you can join the study, although some ongoing mild to moderate side effects that are stable and well-controlled may be acceptable
  • You must have a reasonable life expectancy as determined by your doctor
  • If you are able to have children, you must agree to use birth control methods as required by local regulations during the study
  • Your blood counts and organ function (such as liver and kidneys) must be at adequate levels
  • You must be able to understand the study and sign the informed consent form, which is a document that explains the study details and confirms you agree to participate

Who Cannot Join the Study?

  • No exclusion criteria have been provided in the available study information at this time.

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 Status
Hospital Quironsalud Barcelona Barcelona Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Clara Campal Comprehesive Cancer Center Madrid Spain
Hhoagnqe Vjtq dntbbjhm Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
15.01.2026
Spain Spain
Recruiting
15.01.2026

Trial locations

IPN01203 is an investigational medication being studied for the first time in humans. It is given to patients with advanced or spreading solid tumors (cancers) that have continued to grow despite previous treatment with immune checkpoint inhibitor therapies. This medication works by targeting the immune system to help fight cancer. In this study, it is being tested to find the right dose and to see how safe it is, how well the body processes it, and whether it can help stop or slow down tumor growth.

Investigated diseases:

Advanced Solid Tumor – A solid tumor is an abnormal mass of tissue that does not contain liquid areas or cysts. Advanced solid tumors are cancers that have grown significantly in size or have spread beyond the organ where they originally started. These tumors can affect various parts of the body including the lungs, breast, colon, or other organs. As the disease progresses, the tumor may invade nearby tissues and structures. The term “advanced” indicates that the cancer is in a later stage of development. These tumors continue to grow and may cause symptoms related to their size and location.

Metastatic Solid Tumor – A metastatic solid tumor occurs when cancer cells break away from the original tumor and spread to other parts of the body through the bloodstream or lymphatic system. These cancer cells can form new tumors in distant organs such as the liver, lungs, bones, or brain. The process of cancer spreading from one part of the body to another is called metastasis. Metastatic tumors have the same type of cancer cells as the original tumor. As the disease progresses, multiple areas of the body may become affected by these secondary tumors. The spread of cancer makes the disease more widespread throughout the body.

Trial ID:
2025-522184-15-00
Protocol code:
CLIN-01203-450
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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