Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06305247
PHASE1/PHASE2

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

Sponsor: Ipsen

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2024-04-03

Completion Date

2028-03-20

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

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

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