Actively Recruiting
A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours
Led by Ipsen · Updated on 2026-04-30
85
Participants Needed
13
Research Sites
185 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 a new study drug IPN01195 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.
CONDITIONS
Official Title
A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older or meet the legal age of majority at consent
- Have a confirmed diagnosis of metastatic solid tumor without suitable standard therapy
- Tumors must have specific genetic alterations in the MAPK pathway confirmed by a validated test
- Consent to use archival tumor tissue or fresh biopsy for mutation status confirmation
- Have measurable disease per RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Men and women must use contraception according to local regulations
- Able to provide signed informed consent and comply with study requirements
You will not qualify if you...
- Gastrointestinal conditions impairing absorption of IPN01195 (some cases may be discussed)
- Severe active infection or inflammatory condition
- Inadequate cardiac function
- Psychiatric, substance abuse, or cognitive disorders interfering with study cooperation
- Medical conditions that may obscure toxicity or adverse event interpretation
- Known second malignancy progressing or treated in last 2 years
- Active brain metastases or leptomeningeal disease
- Participation in other investigational treatment studies within last 28 days
- Live vaccines within 28 days prior or planned during study
- Concurrent anti-cancer treatments including radiotherapy or investigational agents
- Less than 28 days washout from prior anti-cancer therapy (exceptions for short half-life drugs)
- Need for systemic corticosteroids (>10 mg prednisone equivalent) or immunosuppressives within 2 weeks prior
- Inadequate bone marrow, renal, or liver function
- Known HIV infection where testing is required
- Uncontrolled or untreated hepatitis B or C infection
- Sensitivity to IPN01195 or its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
START Mid-West
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
2
Sarah Cannon Research Institute (SCRI) - Nashville
Nashville, Tennessee, United States, 37203
Actively Recruiting
3
Mary Crowley Cancer Research Centers - Medical City Hospital - Dallas
Dallas, Texas, United States, 75230
Actively Recruiting
4
START Mountan Region
West Valley City, Utah, United States, 84119
Actively Recruiting
5
Virginia Cancer Specialist- Fairfax
Fairfax, Virginia, United States, 22031
Actively Recruiting
6
Centre Léon Bérard - Lyon
Lyon, France
Not Yet Recruiting
7
Paris Saint-Louis
Paris, France
Actively Recruiting
8
IGR-Villejuif
Villejuif, France
Actively Recruiting
9
Istituto Nazionale dei Tumori
Milan, Italy
Actively Recruiting
10
Istituto Nazionale Tumori IRCCS - Fondazione Pascale
Naples, Italy
Actively Recruiting
11
Val D'Hebron
Barcelona, Spain
Actively Recruiting
12
Hospital Universitario Quirónsalud Madrid
Madrid, Spain
Actively Recruiting
13
M.D. Anderson 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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