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A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours
Sponsor: Ipsen
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
Conditions
Interventions
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
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