A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours
NCT ID: NCT06833008
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
85 participants
INTERVENTIONAL
2025-03-14
2028-10-03
Brief Summary
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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.
Detailed Description
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Phase I will be conducted in two parts:
Part A: Phase I Part A study (dose escalation) is designed to find the dose range showing activity on the tumour that can be tolerated by the participants by testing different doses of IPN01195.
Part B: Phase I Part B of the study (dose confirmation) will assess the ability of study drug to prevent, slow down, or stop the growth of tumours (abnormal cell growths that can lead to cancer) and how the body processes and responds to the study drug when administered in a "low dose" or "high dose" and further explore the safety and tolerability.
These parts will consist of the following periods:
* A period to assess eligibility (screening period).
* A treatment period that will require at least two visits for the first month followed by one visit every month. There will be also one visit, at the end of treatment, at 30 days after the last administration of study drug.
An assessment visit will be required every 6 weeks up to Week 24 and every 12 weeks thereafter to measure the tumour again and to assess how it is evolving, whether it is getting bigger, smaller, is stable or has gone away.
Based on the results obtained from phase I, a phase II extension study will be included through to an updated study plan, to further evaluate the study drug.
In both study phases, participants will undergo blood samplings, urine collections, physical examinations and clinical evaluations. They may continue some other medications, but the details need to be recorded.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A (dose escalation)
IPN01195 will be administered at assigned dose level.
IPN01195
IPN01195 will be administered at assigned dose level.
Part B - (randomisation)
Participants will be randomised to one of the two doses of interest once the PADR is determined
IPN01195
IPN01195 will be administered at assigned dose level.
Interventions
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IPN01195
IPN01195 will be administered at assigned dose level.
Eligibility Criteria
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Inclusion Criteria
* Participants with histologically confirmed metastatic solid tumour for whom no suitable alternative standard therapy exists.
* Participants must bear tumours harbouring selected classes of genetic alterations of MAPK pathway based on an analytically validated assay performed by an accredited laboratory.
* Part A: Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening, for central confirmation of mutation status.
* Part B: Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening, for MAPK genomic testing to confirm eligibility.
* 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
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria
* Any evidence of severe active infection or inflammatory condition.
* Non-adequate cardiac function
* 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 either progressing or requiring active treatment within the last 2 years prior to first dose of the study intervention.
* Active brain metastases or leptomeningeal
* Current enrolment or past participation in any other clinical studies involving an investigational study treatment within the last 28 days
* Live vaccine(s) within 28 days prior to first dose of the study intervention or plan to receive such vaccines during the study.
* Concurrent treatment with any other anti-cancer therapy (including radiotherapy or investigational agents).
* Washout period of less than 28 days prior anti-cancer therapy (including chemotherapy, targeted agents, radiotherapy). If the participant was treated with an agent having a short half-life, washout can be \<28 days but not shorter than 5 times the half-life.
* Condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 2 weeks prior to first dose of the study intervention.
* Non-adequate bone marrow function
* Non-adequate renal function
* Non-adequate hepatic function
* Known human immunodeficiency virus (HIV) infection. HIV testing will be performed in any countries where mandatory per local requirements.
* Known uncontrolled or untreated hepatitis infection.
* (a) Known uncontrolled hepatitis B virus (HBV) infection.
* (b) Known untreated current hepatitis C virus (HCV) infection.
* Sensitivity to IPN01195 or any of its components.
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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START Mid-West
Grand Rapids, Michigan, United States
Sarah Cannon Research Institute (SCRI) - Nashville
Nashville, Tennessee, United States
Mary Crowley Cancer Research Centers - Medical City Hospital - Dallas
Dallas, Texas, United States
START Mountan Region
West Valley City, Utah, United States
Virginia Cancer Specialist- Fairfax
Fairfax, Virginia, United States
Centre Léon Bérard - Lyon
Lyon, , France
Paris Saint-Louis
Paris, , France
IGR-Villejuif
Villejuif, , France
Istituto Nazionale dei Tumori
Milan, , Italy
Istituto Nazionale Tumori IRCCS - Fondazione Pascale
Napoli, , Italy
Val D'Hebron
Barcelona, , Spain
Hospital Universitario Quirónsalud Madrid
Madrid, , Spain
M.D. Anderson Center Madrid
Madrid, , Spain
Countries
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Central Contacts
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Other Identifiers
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CLIN-01195-450
Identifier Type: -
Identifier Source: org_study_id