Phase
Condition
Neoplasms
Treatment
IPN01195
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must be ≥18 years of age or the country's legal age of majority if thelegal age is more than 18 years at the time of signing the informed consent.
Participants with histologically confirmed metastatic solid tumour for whom nosuitable alternative standard therapy exists.
Participants must bear tumours harbouring selected classes of genetic alterations ofMAPK pathway based on an analytically validated assay performed by an accreditedlaboratory.
Part A: Participants must consent to the use of archival tumour tissue or, if notavailable, collection of fresh tumour biopsy at screening, for central confirmationof mutation status.
Part B: Participants must consent to the use of archival tumour tissue or, if notavailable, collection of fresh tumour biopsy at screening, for MAPK genomic testingto confirm eligibility.
Participants must have measurable disease per Response Evaluation Criteria in SolidTumours (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 regulationsregarding the methods of contraception for those participating in clinical studies.
Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the informed consent form (ICF) and in thisprotocol.
Exclusion
Exclusion Criteria:
Gastrointestinal conditions that could impair absorption of IPN01195 (specific casese.g. remote history of gastrointestinal surgery, may be enrolled after discussionwith the medical monitor)
Any evidence of severe active infection or inflammatory condition.
Non-adequate cardiac function
Known psychiatric or substance abuse disorder, or any other cognitive disorder perthe opinion of the investigator that would interfere with the participant's abilityto cooperate with the requirements of the study.
Underlying medical conditions that, in the investigator's or sponsor's opinion, willobscure the interpretation of toxicity determination or AEs.
Known second malignancy either progressing or requiring active treatment within thelast 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 aninvestigational study treatment within the last 28 days
Live vaccine(s) within 28 days prior to first dose of the study intervention or planto receive such vaccines during the study.
Concurrent treatment with any other anti-cancer therapy (including radiotherapy orinvestigational agents).
Washout period of less than 28 days prior anti-cancer therapy (includingchemotherapy, targeted agents, radiotherapy). If the participant was treated with anagent having a short half-life, washout can be <28 days but not shorter than 5 timesthe half-life.
Condition requiring systemic treatment with either corticosteroids (>10 mg dailyprednisone equivalents) or other immunosuppressive medications within 2 weeks priorto 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 inany 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.
Study Design
Study Description
Connect with a study center
Centre Léon Bérard - Lyon
Lyon,
FranceSite Not Available
Paris Saint-Louis
Paris,
FranceSite Not Available
IGR-Villejuif
Villejuif,
FranceSite Not Available
Istituto Nazionale dei Tumori
Milan,
ItalySite Not Available
Istituto Nazionale dei Tumori
Milano,
ItalySite Not Available
Istituto Nazionale Tumori IRCCS - Fondazione Pascale
Napoli,
ItalySite Not Available
Val D'Hebron
Barcelona,
SpainSite Not Available
Hospital Universitario Quirónsalud Madrid
Madrid,
SpainSite Not Available
M.D. Anderson Center Madrid
Madrid,
SpainSite Not Available
START Mid-West
Grand Rapids, Michigan 49546
United StatesActive - Recruiting
Sarah Cannon Research Institute (SCRI) - Nashville
Nashville, Tennessee 37203
United StatesSite Not Available
Mary Crowley Cancer Research Centers - Medical City Hospital - Dallas
Dallas, Texas 75251
United StatesSite Not Available
START Mountan Region
West Valley City, Utah 84119
United StatesActive - Recruiting
Virginia Cancer Specialist- Fairfax
Fairfax, Virginia 22031
United StatesActive - Recruiting
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