Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05908409
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2023-05-03
Brief Title:
A Phase 12 Study of IDP-121 in Patients With RelapsedRefractory Hematologic Malignancies
Sponsor:
IDP Discovery Pharma SL
Organization:
IDP Discovery Pharma SL
Study Overview
Official Title:
A Phase 12 Multicenter Open-label Dose-escalation Study of IDP-121 in Patients With RelapsedRefractory Hematologic Malignancies CASSANDRA
Status:
RECRUITING
Status Verified Date:
2023-09
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:
CASSANDRA
Brief Summary:
The main aims of this 2-part study are
Phase I To determine the maximum tolerated dose MTD and the recommended phase 2 dose RP2D of IDP-121 in patients with multiple myeloma MM diffuse large B cell lymphoma not otherwise specified DLBCL-NOS high-grade B cell lymphoma with double or triple hit rearrangement HGBL-DHTH and HGBL-NOS and chronic lymphocytic leukemia CLL
Phase II To evaluate the overall response rate ORR duration of response DoR time to progression TTP progression-free survival PFS event-free survival EFS and Overall survival OS in patients with MM DLBCL-NOS HGBL-DHTH HGBL-NOS or CLL treated with IDP-121 at the recommended Phase 2 Dose RP2D
Phase I To determine the maximum tolerated dose MTD and the recommended phase 2 dose RP2D of IDP-121 in patients with multiple myeloma MM diffuse large B cell lymphoma not otherwise specified DLBCL-NOS high-grade B cell lymphoma with double or triple hit rearrangement HGBL-DHTH and HGBL-NOS and chronic lymphocytic leukemia CLL
Phase II To evaluate the overall response rate ORR duration of response DoR time to progression TTP progression-free survival PFS event-free survival EFS and Overall survival OS in patients with MM DLBCL-NOS HGBL-DHTH HGBL-NOS or CLL treated with IDP-121 at the recommended Phase 2 Dose RP2D
Detailed Description:
This study is an open-label multicenter Phase 12 study with a Dose-Escalation phase Phase 1 and an Expansion phase Phase 2
Dose-Escalation Phase 1 The dose-escalation phase will follow a classical 33 design but the first patient sentinel will be treated at dose level 1 0015 mgkg for one cycle and if no Dose-Limiting Toxicities DLTs occur at dose level 2 0032 mgkg from cycle 2 onwards Once the patient 1 sentinel is allowed to enter dose level 2 two additional patients will be enrolled to complete the cohort at dose level 2 and the dose-escalation phase will continue the 33 design DLTs will be assessed based on the safety observed in cycle 1 28 days for all patients except for patient 1 sentinel where DLT will be assessed on safety observed in cycle 1 at dose level 1 and cycle 2 at dose level 2 For the first trial patient sentinel a single cycle will be completed 28 days at dose level 0015 mgkg Doses will not be escalated before all patients entered at the current dose level have been treated and observed for at least one complete cycle 28 days at the intended dose- cohort IDP-121 dose and the number of DLTs among those patients in their first cycle has been determined Before each escalation Clinical Investigators will be consulted as part of a cohort review meeting to review and discuss all data including safety PK PD and efficacy data and agree on a dose-escalation as appropriate
During the study the Sponsor and Investigators may request that cohorts be enlarged or that intermediate doses between 2 planned escalation steps be explored based on all data existing at that time including emerging safety and efficacy data and determinations of PK and PD Also the study will allow for alternative IDP-121 doses andor schedules to be evaluated based on emerging data eg once a week dosing of IDP-121 instead of twice a week Data from all patients at all dose levels will be used to guide further dose-escalation orand the MTDRP2D
Expansion-Phase Phase 2 Additional 17 patients will be enrolled for treatment at the RP2D level to further study safety and evaluate efficacy Patients will receive 28-day cycles up to a maximum of 12 cycles of treatment or until any IDP-121 treatment discontinuation criteria are met disease progression unacceptable toxicity etc Patients in the Expansion- Phase may include one or more tumor types from those evaluated in dose-escalation
Dose-Escalation Phase 1 The dose-escalation phase will follow a classical 33 design but the first patient sentinel will be treated at dose level 1 0015 mgkg for one cycle and if no Dose-Limiting Toxicities DLTs occur at dose level 2 0032 mgkg from cycle 2 onwards Once the patient 1 sentinel is allowed to enter dose level 2 two additional patients will be enrolled to complete the cohort at dose level 2 and the dose-escalation phase will continue the 33 design DLTs will be assessed based on the safety observed in cycle 1 28 days for all patients except for patient 1 sentinel where DLT will be assessed on safety observed in cycle 1 at dose level 1 and cycle 2 at dose level 2 For the first trial patient sentinel a single cycle will be completed 28 days at dose level 0015 mgkg Doses will not be escalated before all patients entered at the current dose level have been treated and observed for at least one complete cycle 28 days at the intended dose- cohort IDP-121 dose and the number of DLTs among those patients in their first cycle has been determined Before each escalation Clinical Investigators will be consulted as part of a cohort review meeting to review and discuss all data including safety PK PD and efficacy data and agree on a dose-escalation as appropriate
During the study the Sponsor and Investigators may request that cohorts be enlarged or that intermediate doses between 2 planned escalation steps be explored based on all data existing at that time including emerging safety and efficacy data and determinations of PK and PD Also the study will allow for alternative IDP-121 doses andor schedules to be evaluated based on emerging data eg once a week dosing of IDP-121 instead of twice a week Data from all patients at all dose levels will be used to guide further dose-escalation orand the MTDRP2D
Expansion-Phase Phase 2 Additional 17 patients will be enrolled for treatment at the RP2D level to further study safety and evaluate efficacy Patients will receive 28-day cycles up to a maximum of 12 cycles of treatment or until any IDP-121 treatment discontinuation criteria are met disease progression unacceptable toxicity etc Patients in the Expansion- Phase may include one or more tumor types from those evaluated in dose-escalation
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?:
False
Is an FDA AA801 Violation?:
None