A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Ipsen trials in France
Other trials for the same condition
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