The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new drug, IPN01203, in adults with advanced solid tumours.
Advanced solid tumours are cancers that can occur in various organs or tissues and have spread from their original site to nearby tissues or other parts of the body.
There will be two parts to this study:
* Phase Ia: This part (called dose escalation) will find the dose range that shows activity against the tumour and can be tolerated by participants by testing different increasing doses of IPN01203. * Phase Ib: This part (called dose optimisation) will assess the ability of the drug to prevent, slow down, or stop the growth of tumours and how the body processes and responds to the drug when given in "low dose" or "high dose." It will also further explore the safety and tolerability.
An additional part (phase II) may be added to the study based on the results of phase Ia and phase Ib.
Each part will consist of the following periods:
* A screening period (up to 28 days) to assess whether the participant can take part, requiring at least 1 visit to the study centre. * A treatment period where all eligible participants will receive IPN01203. Requires approximately 15 visits for the first 2 months followed by 3 visits every month from month 3 until unacceptable toxicity, disease progression, death, upon participant's withdrawal of consent, investigator decision, or study termination by the sponsor, whichever occurs first.
There will also be one visit at the end of treatment (EoT), 30 days after the last administration of the study intervention or prior to the start of new anticancer treatment, whichever is earlier. Additionally, there will be one visit (the safety follow-up visit) 90 days after the last administration of study intervention or prior to the start of new anticancer treatment, whichever is earlier.
In both parts of the study, participants will undergo blood sampling, urine collection, physical examinations and clinical evaluations. They may continue some other medications, but the details need to be recorded.
Each participant will be in this study until death or withdrawal from the study. IPN01203 will be provided to participants who tolerate it for as long as their disease does not progress. Participants may withdraw consent to participate at any time.
Participant must be ≥18 years of age, at the time of signing the informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Measurable disease per RECIST version 1.1 (at least one lesion that is measurable by RECIST 1.1. Tumour lesions in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions after radiation) and documented locally advanced or metastatic disease with CT and/or MRI.
All acute, clinically significant (CS) treatment-related AEs from a prior therapy resolved to Grade 1 or lower prior to study entry. Participants with chronic toxicities such as Grade ≤2 neuropathy or alopecia can be included.
Have untreated or active primary brain tumour, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression.
Experienced severe, life-threatening immune-mediated AEs, or infusion-related reactions such as those that lead to permanent discontinuation while on treatment with prior anticancer therapy such as immune checkpoint inhibitor therapy.
History of known autoimmune disease
History of stroke or significant cerebrovascular disease, encephalitis, meningitis, organic brain disease (e,g., Parkinson's disease) or uncontrolled seizures in the year prior to first dose of study drug.
Sequential
IPN01203
Biological/VaccineStudy intervention will be provided in a vial.
Percentage of participants with dose limiting toxicity (DLT)
Percentage of participants experiencing treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TE-SAEs).
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is an AE for which the start date is on or after the date that the intervention began
Phase Ib: Objective Response Rate (ORR)
Defined as the percentage of participants with best overall response (BOR) of complete response (CR) or paritial response (PR), as determined by investigator per RECIST version 1.1.
Phase Ia: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01203.
Phase Ia: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01203
Phase Ia: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01203.
Phase Ia: Percentage of Treatment-Emergent Anti-Drug Antibodies (TEADA), Including Binding and Neutralizing Antibodies.
