NCT06305247
A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours
Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatmentIpsen
~36 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:IPN01194
At a glance
Recruiting sites
0 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1: Percentage of participants with dose limiting toxicity (DLT)
Measured over Within 28 days of first dose
+3 more outcomes measured
Conditions
Where it's being run
11 sites across 6 statesFrance4
Spain3
California1
Connecticut1
Tennessee1
Virginia1
Study leadership
- Ipsen Medical Director · STUDY_DIRECTOR · Ipsen
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Participants must be ≥18 years of age
Participants with histologically confirmed metastatic solid tumour (melanoma, metastatic colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC) or head and neck squamous cell carcinoma (HNSCC)) for whom no suitable alternative standard therapy exists.
Participants must bear tumours harbouring selected classes of genetic mutations, (MAPKm).
Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1
Eastern Cooperative Oncology Group (ECOG)/performance status (PS) of 0 or 1.
Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening
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 trials.
Exclusion
Gastrointestinal conditions that could impair absorption of IPN01194 or inability to swallow oral medications.
Any evidence of severe active infection or inflammatory condition.
Non-adequate cardiac function
Have one or more of study defined ophthalmological findings/conditions
Known psychiatric or substance abuse disorder, or any other cognitive disorder per the opinion of the investigator that would interfere with the participant's ability to cooperate with the requirements of the study.
Underlying medical conditions that, in the investigator's or sponsor's opinion, will obscure the interpretation of toxicity determination or AEs.
Known second malignancy within the last 2 years prior to first dose of study intervention..
Major surgery within 28 days prior to first dose of study intervention.
Ongoing AEs caused by any prior anti-cancer therapy ≥Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0).
Active brain metastases or leptomeningeal metastases
Current enrolment or past participation in any other clinical trial involving an investigational study treatment within the last 28 days.
Live vaccine(s) within 28 days prior to first dose of study intervention
Concurrent treatment with any other anti-cancer therapy (including radiotherapy or investigational agents).
Treatment with medications that prolong the QT/QTc interval.
Treatment with strong and moderate CYP3A4 inducers
Treatment with strong or moderate inhibitors of CYP3A4
Only for Phase I participants assigned to dose escalation and low-dose backfill participants: treatment with proton pump inhibitors within 14 days prior to first dose of study intervention.
Non-adequate bone marrow function
Non-adequate renal function
Non-adequate hepatic function
Non adequate coagulation function.
Known uncontrolled human immunodeficiency virus (HIV) infection or hepatitis B or C
Sensitivity to IPN01194 or any of its components.
What this trial measures
- Phase 1: Percentage of participants with dose limiting toxicity (DLT)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)At 30 days following the last administration of study intervention
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.
- Phase 1: Percentage of participants with dose interruptions and permanent treatment discontinuationsAt 30 days following the last administration of study intervention
- Phase 2a: Objective response rate (ORR)At end of treatment (up to approximately 32 months)
Defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator.