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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Melanoma, Head and Neck Squamous Cell Carcinoma, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Solid Tumor

In brief

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).

Key facts

Study ID

NCT06305247

Run by

Ipsen

People needed

36

Starts

2024-04-03

Expected to finish

2028-03-20

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Angeles Clinic and Research Institute - California — Los Angeles, California, United States
• Yale Cancer Center - New Heaven — New Haven, Connecticut, United States
• Sarah Cannon Research Institute (SCRI) - Nashville — Nashville, Tennessee, United States
• Virginia Cancer Specialist — Fairfax, Virginia, United States
• Centre Léon Bérard - Lyon — Lyon, France
• Paris Saint-Louis — Paris, France
• Institut de Cancerologie de l'Ouest (St-Herblain) — Saint-Herblain, France
• IGR-Villejuif — Villejuif, France
• Barcelona - Val D'Hebron — Barcelona, Spain
• Fundacion Jimenez Diaz - Madrid — Madrid, Spain
• M.D. Anderson Cancer Center Madrid — Madrid, Spain

Full record on ClinicalTrials.gov

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