An Open-label, Phase I/II First-in-human, Dose Escalation and Confirmation Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Anti-tumour Activity of IPN01195 as Single Agent in Adult Participants With Advanced Solid Tumours
Ipsen
Summary
The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new study drug IPN01195 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.
Description
The study consists of two phases, called phase I and phase II. Phase I will be conducted in two parts: Part A: Phase I Part A study (dose escalation) is designed to find the dose range showing activity on the tumour that can be tolerated by the participants by testing different doses of IPN01195. Part B: Phase I Part B of the study (dose confirmation) will assess the ability of study drug to prevent, slow down, or stop the growth of tumours (abnormal cell growths that can lead to cancer) and how the body processes and responds to the study drug when administered in a "low dose" or "high dos…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must be ≥18 years of age or the country's legal age of majority if the legal age is more than 18 years at the time of signing the informed consent. * Participants with histologically confirmed metastatic solid tumour for whom no suitable alternative standard therapy exists. * Participants must bear tumours harbouring selected classes of genetic alterations of MAPK pathway based on an analytically validated assay performed by an accredited laboratory. * Part A: Participants must consent to the use of archival tumour tissue or, if not available, collection of…
Interventions
- DrugIPN01195
IPN01195 will be administered at assigned dose level.
Locations (13)
- START Mid-WestGrand Rapids, Michigan
- Sarah Cannon Research Institute (SCRI) - NashvilleNashville, Tennessee
- Mary Crowley Cancer Research Centers - Medical City Hospital - DallasDallas, Texas
- START Mountan RegionWest Valley City, Utah
- Virginia Cancer Specialist- FairfaxFairfax, Virginia
- Centre Léon Bérard - LyonLyon