Advanced Solid Tumor, Metastatic Solid Tumor
Conditions
Brief 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.
Interventions
BIOLOGICALIPN01203
Study intervention will be provided in a vial.
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Part 1a is sequential assignment - non-randomized, single arm. Part 1b is randomized, two-arm, parallel design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 a life expectancy for disease-related mortality, as evaluated by the investigator. * Male and female participants: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Adequate haematologic and end organ function * Participant is capable of giving signed informed consent as described in the protocol.
Exclusion criteria
* 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. * History of CS cardiac disease within 6 months prior to the initiation of study intervention, including but not limited to unstable angina, acute myocardial infarction, endoscopic or open-heart cardiac surgery, or heart failure classified as New York Heart Association Grade 2 or higher. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with dose limiting toxicity (DLT) | Within 28 days of first dose | — |
| Percentage of participants experiencing treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TE-SAEs). | From the first IPN01203 administration to 90 days after the last dose. | 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) | At end of study (up to approximately 3 years) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase Ia: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01203. | Up to 28 days after study drug administration. | — |
| Phase Ia: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01203 | 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. | Up to 28 days after study drug administration. | — |
| Phase Ia: Percentage of Treatment-Emergent Anti-Drug Antibodies (TEADA), Including Binding and Neutralizing Antibodies. | 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) | At end of study (up to approximately 3 years) | ORR is defined as the percentage of participants with BOR of CR or PR, as determined by investigator per RECIST version 1.1. |
| Phase Ib: Duration of response (DoR) | At end of study (up to approximately 3 years) | 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. |
| Phase Ib: Duration of stable disease (SD) | At end of study (up to approximately 3 years) | 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. |
| Phase Ib: Progression-free survival (PFS) | At end of study (up to approximately 3 years) | 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. |
| Phase Ib: Disease control rate (DCR) | From the first IPN01203 administration throughout the study (up to approximately 3 years). | 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. |
| Phase Ib: Time to response (TTR) | From the first IPN01203 administration throughout the study (up to approximately 3 years). | 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. |
| Phase Ib: Percentage of Treatment-Emergent Anti-Drug Antibodies (TEADA), Including Binding and Neutralizing Antibodies. | From predose to end of treatment (up to approximately 3 years). | — |
Countries
Canada, France, Spain, United States
Contacts
CONTACTIpsen Clinical Study Enquiries
STUDY_DIRECTORIpsen Medical Director
Ipsen
Outcome results
None listed