A Phase 1/2 interventional study of IPN01194 and IPN01194 in Melanoma, Head and Neck Squamous Cell Carcinoma and Pancreatic Ductal Adenocarcinoma, sponsored by Ipsen. Active, not recruiting at 12 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Ipsen · Phase 1/2, Interventional, and Treatment
The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 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.
In this study, all participants will receive the study drug, which will be taken by mouth (orally).
The study consists of two parts, called Phase I and Phase IIa.
Phase I is designed to assess the safety of increasing doses of IPN01194 in participants with specific types of advanced solid tumours.
The aim of this "dose escalation" phase is to find the dose range showing activity on the tumor that can be tolerated by the participants, and to determine the two doses for further testing in Phase IIa. Phase I will assess how the body processes and responds to the study drug when administered with and without food.
In Phase IIa, participants with selected single tumour type will be invited to take part. During this phase, the two dose levels of the study drug identified from Phase I will be tested. Participants will take the study drug one of the two dose levels. Each participant will be assigned to a dose level at random (by chance).
Each phase will consist of three periods:
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.
If in the opinion of the investigator a participant is continuing to experience clinical benefit after the cut-off date, the participant may remain in the study and continue to receive the study drug until either disease progression, unacceptable toxicity or other withdrawal criteria are met.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 36 is close to the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Nine dose levels are planned to be tested.
Drug: IPN01194
Study intervention will be administered at one of two doses of interest determined at the end of Phase I.
Drug: IPN01194
IPN01194 will be taken orally over a period of 28 days (a "Cycle") at the assigned dose level. The dose limiting toxicity (DLT) observation period consists of the first 28 days of treatment with IPN01194 (Cycle 1). Participants will receive IPN01194 treatment beyond Cycle 1 until treatment is precluded by toxicity, disease progression, or upon participant's request or investigator decision.
All participants will receive IPN01194 orally for 28-day cycles at one of the two dose levels determined at the end of Phase I. Participants will receive IPN01194 treatment until treatment is precluded by toxicity, disease progression, or upon participant's request or investigator decision
Phase 1: Percentage of participants with dose limiting toxicity (DLT)
Time frame: Within 28 days of first dose
Phase 1: 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.
Time frame: At 30 days following the last administration of study intervention
Phase 1: Percentage of participants with dose interruptions and permanent treatment discontinuations
Time frame: At 30 days following the last administration of study intervention
Phase 2a: Objective response rate (ORR)
Defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator.
Time frame: At end of treatment (up to approximately 32 months)
Phase 1: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01194
Time frame: At Day 1 and Day 15.
Phase 1: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01194
Time frame: At Day 1 and Day 15.
Phase 1: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01194
AUCtau is defined as the concentration of drug over one dosing interval.
Time frame: At Day 1 and Day 15.
Phase 1: Geometric mean ratio of Cmax of IPN01194 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)
Phase 1: Geometric mean ratio of AUClast of IPN01194 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)
Phase 1: Geometric mean ratio of AUCinf 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)
Phase 1: 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
Phase 1: 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).
Time frame: At end of treatment (up to approximately 32 months)
Phase 2a: Duration of response (DoR)
Defined as the percentage of participants with BOR of CR or PR, as determined by investigator per RECIST version 1.1
Time frame: From randomisation to end of treatment (up to approximately 32 months)
Phase 2a: Progression-free survival (PFS)
PFS is defined as the time from the date of randomisation to the date of the first documented disease progression, as determined by investigator per RECIST version 1.1.
Time frame: From randomisation to end of treatment (up to approximately 32 months)
Phase 2a: PFS rate at 4 months
Time frame: From randomisation to 4 months
Phase 2a: 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: At end of treatment (up to approximately 32 months)
Phase 2a: Percentage of participants with TEAEs and TE SAEs
Time frame: At end of treatment (up to approximately 32 months)
Phase 2a: Percentage of participants with dose interruptions and permanent treatment discontinuations
Time frame: At end of treatment (up to approximately 32 months)
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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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