An Open-label, Phase I/IIa First-in-human, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Antitumour Activity of ERK1/2 Inhibitor IPN01194 as Single Agent in Adult Participants With Advanced Solid Tumours

Study Identifier:
CLIN-01194-450
CT.gov Identifier:
NCT06305247
EudraCT Identifier:
202351000000
EU Trial (CTIS) Number:
2023-506228-10-00
Study Contact Information:
N/A
Recruiting

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Study Summary

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).

Main objective

1. Phase 1: Percentage of participants with dose limiting toxicity (DLT)

2. Phase 1: Percentage of participants experiencing treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TE SAEs). 3. Phase 1: Percentage of participants with dose interruptions and permanent treatment discontinuations

4. Phase 2a: Objective response rate (ORR)

To assess safety, tolerability, pharmacokinetic (PK), pharmacodynamic and clinical activity of IPN01194 as monotherapy in patients with MAPKm solid tumours.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Melanoma
  • Head & Neck
  • Pancreas
  • Bowel (Colorectal)
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Phase I (Dose Escalation with Backfilling)
    • Read More
  • Drug: Participants will receive IPN01194 treatment beyond Cycle 1 until treatment is precluded by toxicity, disease progression, or upon participant's request or investigator decision.
  • Drug: Experimental: Phase IIa (Cohort Expansion)
  • Drug: Participants will receive IPN01194 treatment until treatment is precluded by toxicity, disease progression, or upon participant's request or investigator decision
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Inclusion Criteria :
    • - Participants must be ≥18 years of age
    • - Participants with histologically confirmed metastatic solid tumour (melanoma,
    • metastatic colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC) or head
    • and neck squamous cell carcinoma (HNSCC)) for whom no suitable alternative standard
    • therapy exists.
    • - Participants must bear tumours harbouring selected classes of genetic mutations,
    • (MAPKm).
    • - 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.
    • - Participants must consent to the use of archival tumour tissue or, if not available,
    • collection of fresh tumour biopsy at screening
    • - Male and female participants Contraceptive use by men or women should be consistent
    • with local regulations
    • Pts with metastatic melanoma, CRC, PDAC or HNSCC harbouring mutations of the MAPK pathway with an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1. regarding the methods of contraception for those participating
    • in clinical trials.
    Exclusion criteria
    • Exclusion Criteria
    • - Gastrointestinal conditions that could impair absorption of IPN01194 or inability to
    • swallow oral medications.
    • - Any evidence of severe active infection or inflammatory condition.
    • - Non-adequate cardiac function
    • - Have one or more of study defined ophthalmological findings/conditions
    • - 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 within the last 2 years prior to first dose of study
    • intervention..
    • - Major surgery within 28 days prior to first dose of study intervention.
    • - Ongoing AEs caused by any prior anti-cancer therapy ≥Grade 2 (National Cancer
    • Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0).
    • - Active brain metastases or leptomeningeal metastases
    • - Current enrolment or past participation in any other clinical trial involving an
    • investigational study treatment within the last 28 days.
    • - Live vaccine(s) within 28 days prior to first dose of study intervention
    • - Concurrent treatment with any other anti-cancer therapy (including radiotherapy or
    • investigational agents).
    • - Treatment with medications that prolong the QT/QTc interval.
    • - Treatment with strong and moderate CYP3A4 inducers
    • - Treatment with strong or moderate inhibitors of CYP3A4
    • - Only for Phase I participants assigned to dose escalation and low-dose backfill
    • participants: treatment with proton pump inhibitors within 14 days prior to first dose
    • of study intervention.
    • - Non-adequate bone marrow function
    • - Non-adequate renal function
    • - Non-adequate hepatic function
    • - Non adequate coagulation function.
    • - Known uncontrolled human immunodeficiency virus (HIV) infection or hepatitis B or C
    • - Sensitivity to IPN01194 or any of its components.
    • Exclusion criteria include concomitant illness and conditions potentially affecting IPN01194 absorption.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Bernard Doger de Speville
    Status
    Recruiting
    Condition(s) Treated at Site
    Melanoma
    Head & Neck
    Pancreas
    Bowel (Colorectal)
    Solid Tumor