A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours
- Conditions
- Melanoma, Head and Neck Squamous Cell Carcinoma, Solid tumors, Pancreatic Ductal Adenocarcinoma, Colorectal CancerMedDRA version: 21.1Level: LLTClassification code: 10051971Term: Pancreatic adenocarcinoma Class: 10029104MedDRA version: 21.1Level: LLTClassification code: 10053571Term: Melanoma Class: 10029104MedDRA version: 21.0Level: PTClassification code: 10061451Term: Colorectal cancer Class: 100000004864MedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104MedDRA version: 21.1Level: PTClassification code: 10067821Term: Head and neck cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-506228-10-00
- Lead Sponsor
- Ipsen Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Participants must be =18 years of age, Participants with histologically confirmed metastatic solid tumour (melanoma, CRC, PDAC or 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
Gastrointestinal conditions that could impair absorption of IPN01194 or inability to swallow oral medications, Non-adequate bone marrow function, Non-adequate renal function, Any evidence of severe active infection or inflammatory condition, 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, 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, Active brain metastases or leptomeningeal metastases, 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)., France-specific: participants under court protection, not affiliated to a social security system or protected adults., 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method