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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Study intervention will be provided in a vial.
START MidWest PI Sharma
Grand Rapids, Michigan, United States
RECRUITINGSarah Cannon Research Institute PI McKean Nasville, TN, USA
Nashville, Tennessee, United States
NOT_YET_RECRUITINGMD Anderson PI Champiat
Houston, Texas, United States
NOT_YET_RECRUITINGStart San Antonio PI Rasco
San Antonio, Texas, United States
RECRUITINGNEXT PI Spira
Fairfax, Virginia, United States
NOT_YET_RECRUITINGPrincess Margaret Cancer Center PI Spreafico
Toronto, Canada
NOT_YET_RECRUITINGGustave Roussy Cancer Campus Grand Paris- (Institut de Cancerologie Gustave-Roussy) - PI Ronan
Villejuif, France
NOT_YET_RECRUITINGHospital Universitario Vall d'Hebron PI Garralda Cabanas
Barcelona, Spain
NOT_YET_RECRUITINGNEXT Quiron-Barcelona - PI Saavedra Santa Gadea
Barcelona, Spain
NOT_YET_RECRUITINGSTART Madrid - CIOCC. Grupo Hospital de Madrid (HM) - Centro Integral Oncologico Clara Campal (CIOCC) - Calvo Aller
Madrid, Spain
NOT_YET_RECRUITINGPercentage of participants with dose limiting toxicity (DLT)
Time frame: Within 28 days of first dose
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
Time frame: From the first IPN01203 administration to 90 days after the last dose.
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.
Time frame: At end of study (up to approximately 3 years)
Phase Ia: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01203.
Time frame: Up to 28 days after study drug administration.
Phase Ia: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01203
Time frame: Up to 28 days after study drug administration.
Phase Ia: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01203.
Time frame: Up to 28 days after study drug administration.
Phase Ia: Percentage of Treatment-Emergent Anti-Drug Antibodies (TEADA), Including Binding and Neutralizing Antibodies.
Time frame: From the first dose of study drug administration, at predefined intervals until the end of study (up to approximately 3 years)
Phase Ia: Objective response rate (ORR)
ORR is defined as the percentage of participants with BOR of CR or PR, as determined by investigator per RECIST version 1.1.
Time frame: At end of study (up to approximately 3 years)
Phase Ib: Duration of response (DoR)
DoR is defined as the time from first documented evidence of CR or PR until progressive disease, as determined by investigator per RECIST version 1.1, or death from any cause, whichever occurs first.
Time frame: At end of study (up to approximately 3 years)
Phase Ib: Duration of stable disease (SD)
SD is defined as the time from the date of first IPN01203 administration to the date of the first documented disease progression, as determined by investigator per RECIST version 1.1, or death due to any cause, whichever occurs first, for participants with SD as best response, with a minimum SD duration of 8 weeks.
Time frame: At end of study (up to approximately 3 years)
Phase Ib: Progression-free survival (PFS)
PFS is defined as the time from the date of first IPN01203 administration to the date of the first documented disease progression, as determined by investigator per RECIST version 1.1, or death due to any cause, whichever occurs first.
Time frame: At end of study (up to approximately 3 years)
Phase Ib: Disease control rate (DCR)
DCR is defined as the percentage of participants with BOR of CR, PR, or SD, as determined by investigator per RECIST version 1.1, from the first IPN01203 administration throughout the study.
Time frame: From the first IPN01203 administration throughout the study (up to approximately 3 years).
Phase Ib: Time to response (TTR)
TTR is defined as the time between date of start of treatment until first documented response (CR or PR), as determined by investigator per RECIST version 1.1.
Time frame: From the first IPN01203 administration throughout the study (up to approximately 3 years).
Phase Ib: Percentage of Treatment-Emergent Anti-Drug Antibodies (TEADA), Including Binding and Neutralizing Antibodies.
Time frame: From predose to end of treatment (up to approximately 3 years).
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