A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours
- Conditions
- Pancreatic Ductal AdenocarcinomaColorectal CancerSolid TumorMelanomaHead and Neck Squamous Cell Carcinoma
- Interventions
- Registration Number
- NCT06305247
- Lead Sponsor
- Ipsen
- Brief 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).
- Detailed Description
The study consists of two parts, called Phase I and Phase IIa.
Phase I is designed to assess the safety of increasing doses of IPN01194 in participants with specific types of advanced solid tumours.
The aim of this "dose escalation" phase is to find the dose range showing activity on the tumor that can be tolerated by the participants, and to determine the two doses for further testing in Phase IIa. Phase I will assess how the body processes and responds to the study drug when administered with and without food.
In Phase IIa, participants with selected single tumour type will be invited to take part. During this phase, the two dose levels of the study drug identified from Phase I will be tested. Participants will take the study drug one of the two dose levels. Each participant will be assigned to a dose level at random (by chance).
Each phase will consist of three periods:
1. A period to assess eligibility (screening period) that will take up to 28 days.
2. A treatment period of at least 28 days 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 least 30 days after the last administration of study drug.
3. A follow-up period (Phase IIa participants only), where every 3 months, participants will be contacted by phone, until death or the study cut-off date, whichever comes first.
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.
If in the opinion of the investigator a participant is continuing to experience clinical benefit after the cut-off date, the participant may remain in the study and continue to receive the study drug until either disease progression, unacceptable toxicity or other withdrawal criteria are met.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 220
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase IIa (Cohort Expansion) IPN01194 Study intervention will be administered at one of two doses of interest determined at the end of Phase I. Phase I (Dose Escalation with Backfilling) IPN01194 Nine dose levels are planned to be tested.
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method Phase 1: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01194 At Day 1 and Day 15. AUCtau is defined as the concentration of drug over one dosing interval.
Phase 2a: Disease control rate (DCR) At end of treatment (up to approximately 32 months) DCR is defined as the percentage of participants with BOR of CR, PR or stable disease (SD), as determined by investigator per RECIST version 1.1.
Phase 1: Geometric mean ratio of Cmax of IPN01194 administered in fed state relative to fasted state Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period) Phase 1: Prolongation of corrected QT interval (QTc) Within 28 days of first dose Prolongation of QTc defined as the upper limit of 90% confidence interval for change from baseline QTc evaluated over Cycle 1 at the highest clinically relevant exposure.
Phase 2a: Percentage of participants with TEAEs and TE SAEs At end of treatment (up to approximately 32 months) Phase 1: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01194 At Day 1 and Day 15. Phase 1: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01194 At Day 1 and Day 15. Phase 1: Geometric mean ratio of AUCinf administered in fed state relative to fasted state Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period) AUCinf is defined as the concentration of drug extrapolated to infinite time.
Phase 2a: Duration of response (DoR) From randomisation to end of treatment (up to approximately 32 months) Defined as the percentage of participants with BOR of CR or PR, as determined by investigator per RECIST version 1.1
Phase 1: Objective response rate (ORR) At end of treatment (up to approximately 32 months) The ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR).
Phase 1: Geometric mean ratio of AUClast of IPN01194 administered in fed state relative to fasted state Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period) AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Phase 2a: Progression-free survival (PFS) From randomisation to end of treatment (up to approximately 32 months) PFS is defined as the time from the date of randomisation to the date of the first documented disease progression, as determined by investigator per RECIST version 1.1.
Phase 2a: PFS rate at 4 months From randomisation to 4 months Phase 2a: Percentage of participants with dose interruptions and permanent treatment discontinuations At end of treatment (up to approximately 32 months)
Trial Locations
- Locations (12)
Centre Léon Bérard - Lyon
🇫🇷Lyon, France
Paris Saint-Louis
🇫🇷Paris, France
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
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