A Phase 1/2 interventional study of IPN01203 in Advanced Solid Tumor and Metastatic Solid Tumor, sponsored by Ipsen. Recruiting at 10 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Ipsen · Phase 1/2, Interventional, and Treatment
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:
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:
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.
Exclusion Criteria:
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 exclusion criteria include:
Participants with known history of HIV infection are excluded from the study unless they meet the following criteria:
Participants will receive assigned dose level IPN01203 administered intravenously (IV).
Biological: IPN01203
Participants will randomly receive one of the two doses of interest, determined at the end of Phase Ia, of IPN01203 administered intravenously (IV).
Biological: IPN01203
Study intervention will be provided in a vial.
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)
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).
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
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