A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours

Official record

Identifier

NCT06305247

Recruiting locations

countries

United StatesFranceSpain

Interventions studied

IPN01194IPN01194

Lead sponsor

Ipsen

Target enrolment

36 participants

Study type

INTERVENTIONAL

Phase

Phase 1/2

Status

Active, not recruiting

First posted

Mar 12, 2024

Last updated on the registry

Jul 30, 2026

Age

18 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria :

* 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 Criteria

* 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.