An Open-label, Phase I/II First in Human, Dose Escalation, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Participants With Locally Advanced or Metastatic Solid Tumours Who Have Progressed on or After Immune Checkpoint Inhibitor Therapies
Summary
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.
Arms & interventions
- BiologicalIPN01203
Study intervention will be provided in a vial.
Outcome measures
Primary
Percentage 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)
Secondary
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)
Time frame: At end of study (up to approximately 3 years)
Phase Ib: Duration of response (DoR)
Time frame: At end of study (up to approximately 3 years)
Phase Ib: Duration of stable disease (SD)
Time frame: At end of study (up to approximately 3 years)
Phase Ib: Progression-free survival (PFS)
Time frame: At end of study (up to approximately 3 years)
Phase Ib: Disease control rate (DCR)
Time frame: From the first IPN01203 administration throughout the study (up to approximately 3 years).
Phase Ib: Time to response (TTR)
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).
Eligibility criteria
Study locations (6)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
START MidWest PI Sharma
Grand Rapids, Michigan, 49546
Sarah Cannon Research Institute PI McKean Nasville, TN, USA
Nashville, Tennessee, 37205
MD Anderson PI Champiat
Houston, Texas, 77030
Start San Antonio PI Rasco
San Antonio, Texas, 78229
NEXT PI Spira
Fairfax, Virginia, 22031