A Phase 1/2 interventional study of IPN01195 in Advanced Solid Tumor, sponsored by Ipsen. Recruiting at 13 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
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 study drug IPN01195 in adults with advanced solid tumours.
The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body.
The study consists of two phases, called phase I and phase II.
Phase I will be conducted in two parts:
Part A: Phase I Part A study (dose escalation) is designed to find the dose range showing activity on the tumour that can be tolerated by the participants by testing different doses of IPN01195.
Part B: Phase I Part B of the study (dose confirmation) will assess the ability of study drug to prevent, slow down, or stop the growth of tumours (abnormal cell growths that can lead to cancer) and how the body processes and responds to the study drug when administered in a "low dose" or "high dose" and further explore the safety and tolerability.
These parts will consist of the following periods:
An assessment visit will be required every 6 weeks up to Week 24 and every 12 weeks thereafter to measure the tumour again and to assess how it is evolving, whether it is getting bigger, smaller, is stable or has gone away.
Based on the results obtained from phase I, a phase II extension study will be included through to an updated study plan, to further evaluate the study drug.
In both study phases, participants will undergo blood samplings, urine collections, physical examinations and clinical evaluations. They may continue some other medications, but the details need to be recorded.
Exclusion Criteria:
Known uncontrolled or untreated hepatitis infection.
IPN01195 will be administered at assigned dose level.
Drug: IPN01195
Participants will be randomised to one of the two doses of interest once the PADR is determined
Drug: IPN01195
IPN01195 will be administered at assigned dose level.
Part A: Percentage of participants with dose limiting toxicity (DLT)
Time frame: Part A: within 28 days of first dose.
Part A and B: 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 IPN01195 administration to 30 days after last dose.
Part A and B: Percentage of participants with dose interruptions and permanent treatment discontinuations
Time frame: From the first study drug administration to 30 days after last dose.
Part B: Objective response rate (ORR)
Objective response rate 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.
Time frame: Part B: At end of study (up to approximately 3 years)
Part A: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01195
Time frame: Cycle 1: at Day 1 and at Day 15.
Part A: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01195
Time frame: Cycle 1: at Day 1 and at Day 15.
Part A: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01195
AUCtau is defined as the concentration of drug over one dosing interval.
Time frame: Cycle 1: at Day 1 and at Day 15.
Part A: Geometric mean ratio of Cmax of IPN01195 administered in fed state relative to fasted state.
Time frame: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)
Part A: Geometric mean ratio of AUClast of IPN01195 administered in fed state relative to fasted state
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Time frame: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)
Part A: Geometric mean ratio of AUCinf of IPN01195 administered in fed state relative to fasted state
AUCinf is defined as the concentration of drug extrapolated to infinite time.
Time frame: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)
Part A: Prolongation of corrected QT interval (QTc)
Prolongation of QTc defined as the upper limit of 90% confidence interval for change from baseline QTc evaluated over Cycle 1 at the highest clinically relevant exposure.
Time frame: Within 28 days of first dose.
Part A: Objective response rate (ORR)
The 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
Time frame: Part A: From first study drug administration to end of study (up to approximately 3 years)
Part B: Duration of response (DoR)
DoR defined as the time from first documented evidence of CR or PR until progressive disease, as determined by investigator per RECIST version 1.1.
Time frame: Every 3 months until end of study or death (up to approximately 3 years)
Part B: Progression-free survival (PFS)
PFS is defined as the time from the date of first IPN01195 administration to the date of the first documented disease progression, as determined by investigator per RECIST version 1.1.
Time frame: From first study drug administration to end of study (up to approximately 3 years)
Part B: PFS rate at 4 months
PFS rate at 4 months defined as the proportion of participants who remain alive and progression-free at 4 months, as determined by investigator per RECIST version 1.1.
Time frame: At Month 4
Part B: Disease control rate (DCR).
DCR is defined as the percentage of participants with BOR of CR, PR or stable disease (SD), as determined by investigator per RECIST version 1.1
Time frame: Part B:From first study drug administration to end of study (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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