This study aims to find the right dosage and evaluate the safety and effectiveness of the drug IPN60300 in adults with advanced solid tumours, which are cancers that have spread to other parts of the body from their original location. All participants will receive the drug by injection.
Study Phases:
* Phase Ia: Participants with certain types of tumours will be treated in cohorts of increasingly higher doses of the drug to determine the safe and effective dose range (a high and a low dose). * Phase Ib: Participants with a specific tumour type will receive one of the two doses identified in phase Ia. The dose level will be assigned randomly (by chance).
Study Periods:
Screening: Up to 28 days before first IPN60300 injection to determine eligibility.
Treatment: Starts with the first dose of IPN60300 and continues until it needs to be stopped due to harmful effects, the disease getting worse, or if the participant decides to stop taking part in the study, the investigator's decision to stop treatment, death or the study is terminated early by the sponsor.
Participants will undergo blood tests, urine collections, physical examinations, and clinical evaluations.
Participant must be ≥18 years of age, at the time of signing the informed consent.
Participants with histologically or cytologically documented, locally advanced, or metastatic solid tumors, that relapsed or were refractory after being previously treated with standard of care therapy; or for which there is no available established therapy; or standard therapy is contraindicated or not deemed appropriate by the treating investigator.
Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Known second malignancy either progressing or requiring active treatment within the last 2 years prior to first dose of study intervention.
Residual toxicity from prior anticancer therapy that are NCI CTCAE version 5.0 Grade 2 or higher. Stable chronic Grade 2 toxicities from previous treatments may be eligible per the judgement of investigator.
History of major surgery within 4 weeks prior to the first dose of study intervention.
Previous solid organ transplantation.
Sequential
IPN60300
Biological/VaccineIPN60300 will be administered at assigned dose level.
Phase Ia: Percentage of participants with dose limiting toxicity (DLT)
Phase Ia and Ib: 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. A TEAE is an AE for which the start date is on or after the date that the intervention began or it was present prior to receiving the intervention but the intensity increased during the active phase of the study.
Phase Ib: Objective response rate (ORR)
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR), as determined by investigator per RECIST version 1.1
Phase Ia: Time to maximum observed drug concentration (tmax) of IPN60300 after single and multiple doses of IPN60300
Phase Ia: Maximum observed drug concentration (cmax) of IPN60300 after single and multiple doses of IPN60300
Phase Ia: Area under the plasma concentration time curve over one dosing interval (AUCtau) of IPN60300 after single and multiple doses of IPN60300
Phase Ia: Tmax of Total Antibody after single and multiple doses of IPN60300
