Actively Recruiting
A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours
Led by Ipsen · Updated on 2026-04-30
220
Participants Needed
12
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years of age or older
- Participants must have a confirmed metastatic solid tumor (melanoma, colorectal cancer, pancreatic ductal adenocarcinoma, or head and neck squamous cell carcinoma) without suitable alternative standard therapy
- Tumors must have selected genetic mutations (MAPKm)
- Participants must have measurable disease according to RECIST version 1.1
- Performance status must be ECOG 0 or 1
- Participants must consent to use of archival tumor tissue or agree to provide fresh biopsy at screening
- Male and female participants must use contraception according to local regulations during the trial
You will not qualify if you...
- Gastrointestinal conditions that impair absorption of IPN01194 or inability to swallow oral medications
- Severe active infection or inflammatory condition
- Inadequate cardiac function
- Specific ophthalmological findings or conditions defined by the study
- Known psychiatric, substance abuse, or cognitive disorders interfering with study participation
- Medical conditions that may interfere with toxicity assessment
- Known second malignancy within 2 years prior to first dose
- Major surgery within 28 days prior to first dose
- Ongoing adverse events from prior anti-cancer therapy at Grade 2 or higher
- Active brain or leptomeningeal metastases
- Participation in another investigational trial within 28 days
- Live vaccine within 28 days prior to first dose
- Concurrent anti-cancer therapy including radiotherapy or investigational agents
- Treatment with medications that prolong QT/QTc interval
- Treatment with strong or moderate CYP3A4 inducers or inhibitors
- For Phase I dose escalation participants: proton pump inhibitor use within 14 days prior to first dose
- Inadequate bone marrow, renal, hepatic, or coagulation function
- Uncontrolled HIV infection or hepatitis B or C
- Sensitivity to IPN01194 or its components
AI-Screening
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Trial Site Locations
Total: 12 locations
1
The Angeles Clinic and Research Institute - California
Los Angeles, California, United States, 90025
Actively Recruiting
2
UC San Diego Health System - La Jolla
San Diego, California, United States, 92037
Withdrawn
3
Yale Cancer Center - New Heaven
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
Sarah Cannon Research Institute (SCRI) - Nashville
Nashville, Tennessee, United States, 37203
Actively Recruiting
5
Virginia Cancer Specialist
Fairfax, Virginia, United States, 22031
Actively Recruiting
6
Centre Léon Bérard - Lyon
Lyon, France
Actively Recruiting
7
Paris Saint-Louis
Paris, France
Actively Recruiting
8
Institut de Cancerologie de l'Ouest (St-Herblain)
Saint-Herblain, France
Actively Recruiting
9
IGR-Villejuif
Villejuif, France
Actively Recruiting
10
Barcelona - Val D'Hebron
Barcelona, Spain
Actively Recruiting
11
Fundacion Jimenez Diaz - Madrid
Madrid, Spain
Actively Recruiting
12
M.D. Anderson Cancer Center Madrid
Madrid, Spain
Actively Recruiting
Research Team
I
Ipsen Clinical Study Enquiries
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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