A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours
Start Date
3/14/2025
Completion Date
10/3/2028
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.
Detailed 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 dose" and further explore the safety and tolerability. These parts will consist of the following periods: * A period to assess eligibility (screening period). * A treatment period that will require at least two visits for the first month followed by one visit every month. There will be also one visit, at the end of treatment, at 30 days after the last administration of study drug. An assessment visit will be required every 6 weeks up to Week 24 and every 12 weeks thereafter to measure the tumour again and to assess how it is evolving, whether it is getting bigger, smaller, is stable or has gone away. Based on the results obtained from phase I, a phase II extension study will be included through to an updated study plan, to further evaluate the study drug. In both study phases, participants will undergo blood samplings, urine collections, physical examinations and clinical evaluations. They may continue some other medications, but the details need to be recorded.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
IPN01195
Conditions
Locations
START Mid-West
Grand Rapids, Michigan 49546
United States
Sarah Cannon Research Institute (SCRI) - Nashville
Nashville, Tennessee 37203
United States
Mary Crowley Cancer Research Centers - Medical City Hospital - Dallas
Dallas, Texas 75230
United States
START Mountan Region
West Valley City, Utah 84119
United States
Virginia Cancer Specialist- Fairfax
Fairfax, Virginia 22031
United States
Centre Léon Bérard - Lyon
Lyon,
France
Paris Saint-Louis
Paris,
France
IGR-Villejuif
Villejuif,
France
Istituto Nazionale dei Tumori
Milan,
Italy
Istituto Nazionale Tumori IRCCS - Fondazione Pascale
Naples,
Italy
Val D'Hebron
Barcelona,
Spain
Hospital Universitario Quirónsalud Madrid
Madrid,
Spain
M.D. Anderson Center Madrid
Madrid,
Spain