Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305247
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-02-27
Brief Title:
A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours
Sponsor:
Ipsen
Organization:
Ipsen
Study Overview
Official Title:
An Open-label Phase IIIa First-in-human Dose Escalation and Cohort Expansion Study to Evaluate the Safety Tolerability Pharmacokinetic Pharmacodynamic and Antitumour Activity of ERK12 Inhibitor IPN01194 as Single Agent in Adult Participants With Advanced Solid Tumours
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-506228-10-00 | OTHER | Ipsen | None |