Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337630
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-18
Brief Title:
A Study on Tuvusertib Oral ATR Inhibitor in Combination With PLX038 Topo1 Inhibitor in Patients With Advanced Solid Tumors
Sponsor:
Institut Curie
Organization:
Institut Curie
Study Overview
Official Title:
A Phase I Study on Tuvusertib Oral ATR Inhibitor in Combination With PLX038 Topo1 Inhibitor With Dose Expansion Cohorts in Patients With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
POP-ART
Brief Summary:
Phase I with a dose finding cohort followed by expansion cohorts in pre-specified tumor types
Detailed Description:
This is an open label multi-centric phase I with first a dose escalation step using an adaptation of the Bayesian Optimal INterval BOIN drug-combination followed by 2 dose expansion cohorts using the Simon 2-stage design
Dose escalation step Dose escalation will be conducted on the grid defined by the 4 doses of PLX038 800 mgm² 1000 mgm² 1300 mgm² and 1700 mgm² IV every 21 days D1D22 and 3 doses of Tuvusertib 90 mg 130 mg and 180 mg QD for 10 days from D3 D3-12 Premedication with anti-emetic agents is not required prior to the initial infusion but may be used for an individual patient as needed
starting combination level is c1 PLX038 800mgm2 and Tuvusertib 90mg Groups of 3 patients will be sequentially enrolled One week between the enrollment of the 1st patient and the 2 following patients is mandatory at a new combination level The decision to de-escalate one of the two agents depends on the outcome of all patients treated at the current combination
Expansion cohorts Two expansion cohorts are planned investigating the efficacy and safety in pre-specified populations of interest
Patients will be treated at the RP2D 25 evaluable patients are needed in each cohort to account for possible non evaluable patients up to 28 patients will be enrolled in each cohort
Patients enrolled in the phase I part at the RP2D and fulfilling the eligibility criteria of one of the expansion cohorts will be counted in those 25 evaluable patients
Dose escalation step Dose escalation will be conducted on the grid defined by the 4 doses of PLX038 800 mgm² 1000 mgm² 1300 mgm² and 1700 mgm² IV every 21 days D1D22 and 3 doses of Tuvusertib 90 mg 130 mg and 180 mg QD for 10 days from D3 D3-12 Premedication with anti-emetic agents is not required prior to the initial infusion but may be used for an individual patient as needed
starting combination level is c1 PLX038 800mgm2 and Tuvusertib 90mg Groups of 3 patients will be sequentially enrolled One week between the enrollment of the 1st patient and the 2 following patients is mandatory at a new combination level The decision to de-escalate one of the two agents depends on the outcome of all patients treated at the current combination
Expansion cohorts Two expansion cohorts are planned investigating the efficacy and safety in pre-specified populations of interest
Patients will be treated at the RP2D 25 evaluable patients are needed in each cohort to account for possible non evaluable patients up to 28 patients will be enrolled in each cohort
Patients enrolled in the phase I part at the RP2D and fulfilling the eligibility criteria of one of the expansion cohorts will be counted in those 25 evaluable patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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