A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours

Last updated: March 31, 2025
Sponsor: Ipsen
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

IPN01195

Clinical Study ID

NCT06833008
CLIN-01195-450
  • Ages > 18
  • All Genders

Study Summary

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.

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

Total Participants: 85
Treatment Group(s): 1
Primary Treatment: IPN01195
Phase: 1/2
Study Start date:
March 14, 2025
Estimated Completion Date:
October 03, 2028

Study Description

The study consists of two phases, called phase I and phase II.

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.

Connect with a study center

  • Centre Léon Bérard - Lyon

    Lyon,
    France

    Site Not Available

  • Paris Saint-Louis

    Paris,
    France

    Site Not Available

  • IGR-Villejuif

    Villejuif,
    France

    Site Not Available

  • Istituto Nazionale dei Tumori

    Milan,
    Italy

    Site Not Available

  • Istituto Nazionale dei Tumori

    Milano,
    Italy

    Site Not Available

  • Istituto Nazionale Tumori IRCCS - Fondazione Pascale

    Napoli,
    Italy

    Site Not Available

  • Val D'Hebron

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitario Quirónsalud Madrid

    Madrid,
    Spain

    Site Not Available

  • M.D. Anderson Center Madrid

    Madrid,
    Spain

    Site Not Available

  • START Mid-West

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute (SCRI) - Nashville

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Mary Crowley Cancer Research Centers - Medical City Hospital - Dallas

    Dallas, Texas 75251
    United States

    Site Not Available

  • START Mountan Region

    West Valley City, Utah 84119
    United States

    Active - Recruiting

  • Virginia Cancer Specialist- Fairfax

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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