RecruitingPhase 1Phase 2NCT06305247

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

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


Sponsor

Ipsen

Enrollment

220 participants

Start Date

Apr 3, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests the safety and tolerability of a new experimental drug called IPN01194 in people with advanced cancers — specifically melanoma, colorectal cancer, pancreatic cancer, or head and neck cancer — whose tumors carry specific genetic mutations. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with one of these advanced cancers: melanoma, colorectal cancer, pancreatic ductal adenocarcinoma, or head and neck squamous cell carcinoma - Your tumor has specific MAPK-related gene mutations - No suitable standard treatment options remain available for you - Your cancer is measurable on imaging scans - You have a good performance status (ECOG 0 or 1) - You are able to provide tumor tissue for testing **You may NOT be eligible if...** - You have a different type of solid tumor not listed above - Your tumor does not have the required genetic mutations - Your general health or organ function does not meet the study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIPN01194

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.

DRUGIPN01194

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


Locations(12)

The Angeles Clinic and Research Institute - California

Los Angeles, California, United States

UC San Diego Health System - La Jolla

San Diego, California, United States

Yale Cancer Center - New Heaven

New Haven, Connecticut, United States

Sarah Cannon Research Institute (SCRI) - Nashville

Nashville, Tennessee, United States

Virginia Cancer Specialist

Fairfax, Virginia, United States

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

View Full Details on ClinicalTrials.gov

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NCT06305247


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