Phase
Condition
Pancreatic Disorders
Pancreatic Cancer
Neuroblastoma
Treatment
IPN01194
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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.
Study Design
Study Description
Connect with a study center
Centre Léon Bérard - Lyon
Lyon,
FranceActive - Recruiting
Paris Saint-Louis
Paris,
FranceActive - Recruiting
Institut de Cancerologie de l'Ouest (St-Herblain)
Saint-Herblain,
FranceActive - Recruiting
IGR-Villejuif
Villejuif,
FranceActive - Recruiting
Barcelona - Val D'Hebron
Barcelona,
SpainActive - Recruiting
Fundacion Jimenez Diaz - Madrid
Madrid,
SpainActive - Recruiting
M.D. Anderson Cancer Center Madrid
Madrid,
SpainActive - Recruiting
The Angeles Clinic and Research Institute - California
Los Angeles, California 90025
United StatesActive - Recruiting
UC San Diego Health System - La Jolla
San Diego, California 92037
United StatesSite Not Available
Yale Cancer Center - New Heaven
New Haven, Connecticut 06510
United StatesActive - Recruiting
Sarah Cannon Research Institute (SCRI) - Nashville
Nashville, Tennessee 37203
United StatesActive - Recruiting
Virginia Cancer Specialist
Fairfax, Virginia 22031
United StatesActive - Recruiting
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