Ireland
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Active, not recruiting Phase 1/2

A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours

NCT06305247 · tracked via the Priya Life Science France tracker
Sponsor
Phase
Phase 1/2
Started
2024-04-03
Last updated
2026-09-30

Condition(s) studied

MelanomaHead and Neck Squamous Cell CarcinomaPancreatic Ductal AdenocarcinomaColorectal CancerSolid Tumor

Investigational drug(s) / intervention(s)

IPN01194IPN01194

IPN01194: IPN01194 will be taken orally over a period of 28 days (a "Cycle") at the assigned dose level. The dose limiting toxicity (DLT) observation period consists of the first 28 days of treatment with IPN01194 (Cycle 1). Participants will receive IPN01194 treatment beyond Cycle 1 until treatment is precluded by toxicity, disease progression, or upon participant's request or investigator decision.

IPN01194: All participants will receive IPN01194 orally for 28-day cycles at one of the two dose levels determined at the end of Phase I. Participants will receive IPN01194 treatment until treatment is precluded by toxicity, disease progression, or upon participant's request or investigator decision

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 regarding the methods of contraception for those participating in clinical trials. 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.

Primary outcome measure(s)

  • Phase 1: Percentage of participants with dose limiting toxicity (DLT) — Within 28 days of first dose
  • Phase 1: Percentage of participants experiencing Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TE SAEs) — At 30 days following the last administration of study intervention
    An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
  • Phase 1: Percentage of participants with dose interruptions and permanent treatment discontinuations — At 30 days following the last administration of study intervention
  • Phase 2a: Objective response rate (ORR) — At end of treatment (up to approximately 32 months)
    Defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator.

Trial sites (12)

FacilityCityRegionStatus
The Angeles Clinic and Research Institute - California Los Angeles California
UC San Diego Health System - La Jolla San Diego California
Yale Cancer Center - New Heaven New Haven Connecticut
Sarah Cannon Research Institute (SCRI) - Nashville Nashville Tennessee
Virginia Cancer Specialist Fairfax Virginia
Centre Léon Bérard - Lyon Lyon France
Paris Saint-Louis Paris France
Institut de Cancerologie de l'Ouest (St-Herblain) Saint-Herblain France
IGR-Villejuif Villejuif France
Barcelona - Val D'Hebron Barcelona Spain
Fundacion Jimenez Diaz - Madrid Madrid Spain
M.D. Anderson Cancer Center Madrid Madrid Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06305247 on ClinicalTrials.gov ↗ ← All trials in France