Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04640532
Status:
RECRUITING
Last Update Posted:
2022-05-09
First Post:
2020-11-17
Brief Title:
KRT-232 in Combination With TL-895 for the Treatment of RR MF and KRT-232 for the Treatment of JAKi Intolerant MF
Sponsor:
Kartos Therapeutics Inc
Organization:
Kartos Therapeutics Inc
Study Overview
Official Title:
An Open-Label Multicenter Phase 1b2 Study of the Safety and Efficacy of KRT-232 in Combination With TL-895 for the Treatment of Relapsed or Refractory Myelofibrosis and KRT-232 for the Treatment of JAK Inhibitor Intolerant Myelofibrosis
Status:
RECRUITING
Status Verified Date:
2022-05
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:
This study evaluates KRT-232 in Combination With TL-895 for the Treatment of Relapsed or Refractory Myelofibrosis and KRT-232 for the Treatment of JAK Inhibitor Intolerant Myelofibrosis
Detailed Description:
Cohorts 1 and 2 will undergo dose finding and dose expansion Eligible patients will be randomly assigned to an open cohort either Cohort 1 or Cohort 2 Cohort 3 will be conducted as a dose expansion independent of Cohorts 1 and 2
Cohort 1 will follow a 33 dose escalation design to determine the maximum tolerated dose MTDmaximum administered dose MAD and recommended Phase 2 dose RP2D of TL-895 administered QD in combination with KRT-232 A Safety Review Committee SRC will review the safety data during the dose escalation to decide on dose escalation andor exploration of intermediate doses
Cohort 2 will follow a 33 dose escalation design to determine the MTDMAD and recommended RP2D of TL-895 administered BID in combination with KRT-232 An SRC will review the safety data during the dose escalation to decide on dose escalation andor exploration of intermediate doses
Cohort 3 will be conducted a 2-stage design In stage 1 enrollment will continue until 15 evaluable patients have been enrolled An SRC will review the data during the study and if there are 4 responders based on the futility criteria and safety data from Stage 1 Cohort 3 expansion will commence If there are 3 patients responding to therapy Cohort 3 will be terminated Once expansion criteria have been met Cohort 3 will be expanded to a total of 46 evaluable patients for Stage 2 analyses
Cohort 1 will follow a 33 dose escalation design to determine the maximum tolerated dose MTDmaximum administered dose MAD and recommended Phase 2 dose RP2D of TL-895 administered QD in combination with KRT-232 A Safety Review Committee SRC will review the safety data during the dose escalation to decide on dose escalation andor exploration of intermediate doses
Cohort 2 will follow a 33 dose escalation design to determine the MTDMAD and recommended RP2D of TL-895 administered BID in combination with KRT-232 An SRC will review the safety data during the dose escalation to decide on dose escalation andor exploration of intermediate doses
Cohort 3 will be conducted a 2-stage design In stage 1 enrollment will continue until 15 evaluable patients have been enrolled An SRC will review the data during the study and if there are 4 responders based on the futility criteria and safety data from Stage 1 Cohort 3 expansion will commence If there are 3 patients responding to therapy Cohort 3 will be terminated Once expansion criteria have been met Cohort 3 will be expanded to a total of 46 evaluable patients for Stage 2 analyses
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