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

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.

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.

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.

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.

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.