IPN60300 is designed to precisely target cancer cells, reducing off-target effects and increasing the therapeutic index. 

Locally advanced or metastatic solid tumours are cancers that have spread from their original site to nearby tissues or other parts of the body.IPN60300 is a type of medicine called an “antibody-drug conjugate”. An antibody-drug conjugate is made up of an antibody and of a free toxin (the drug) chemically attached to it. Antibodies are special proteins made by the immune system that recognise and attach to some specific proteins. The antibody part of IPN60300 recognises and attaches to a specific protein that is found in larger amounts on certain cancer cells when compared to healthy tissue. So, IPN60300 can attach and deliver the free toxin to the cancer cell, causing it to die. Researchers think that IPN60300 might be better tolerated and might give a better effect compared to the standard of care. This is based on lab results. This study will be the first time IPN60300 is given to people.In this study, researchers want to test how safe and well-tolerated IPN60300 is when given to adults with locally advanced or metastatic solid tumours and to find the best dose of IPN60300 to use to treat cancer. They also want to understand how IPN60300 moves through the body, how it affects the body, whether it causes an immune response, and whether it helps shrink or slow down the cancer.

This study will consist of 3 periods:

• Screening (up to 28 days): to assess whether a participant can take part in the study.
• Treatment: participants will receive treatment in Phase Ia or Ib, in 3-week treatment cycles, until they have an unacceptable side effect, their cancer gets worse, death occurs, or they leave the study either because of the study doctors’ or participants’ decision.
  o Phase Ia (dose escalation): researchers will assess increasing doses of IPN60300 to find a dose range that is safe, well-tolerated, and effective. Researchers may further test the dose with more participants.
  o Phase Ib (dose optimisation): participants will be randomly assigned to either a “low” or
• a “high” dose level of IPN60300, determined based on Phase Ia results.
  o Phase II (optional): based on the results of phase I, a phase II expansion study may be opened for specific tumour types.
• Off-treatment: participants will have an end-of-treatment visit approximately 1 month after the last dose of IPN60300 (or before the start of a new anticancer treatment). Researchers will continue to collect information about the disease status of participants who stop study treatment for reasons other than their cancer getting worse. Participants in Phase

1b will continue to be followed up every 3 months by phone to check their survival status until the end of the study or at any time earlier if participant status is known by the investigator, until death, loss to follow-up, start of a new anticancer therapy, or withdrawal of consent.
IPN60300 will be administered at increasing dose levels as an infusion into the vein on Day 1 of  treatment cycle. Each cycle will last for 21 days. Throughout the study, participants will undergo blood samplings, urine collections, physical examinations, and clinical evaluations.