Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588660
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
ST-067 and Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 1b Study of ST-067 Decoy-Resistant IL-18 With Teclistamab in Multiple Myeloma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase Ib trial tests the safety side effects and best dose of ST-067 in combination with teclistamab and how well it works in treating patients with multiple myeloma that has come back after a period of improvement relapsed or that has not responded to previous treatment refractory ST-067 is an engineered variant of the human cytokine interleukin-18 that may help the immune system kill cancer cells Teclistamab is a bispecific antibody that can bind to two different antigens at the same time Teclistamab binds to B-cell maturation antigen BCMA a protein found on some B-cells and myeloma cells and CD3 on T-cells a type of white blood cell and may interfere with the ability of cancer cells to grow and spread Giving ST-067 in combination with teclistamab may be safe tolerable andor effective in treating patients with relapsed or refractory multiple myeloma
Detailed Description:
OUTLINE This is a dose-escalation study of ST-067 in combination with teclistamab followed by a dose-expansion study
Patients receive ST-067 subcutaneously SC on days 1 8 15 and 22 of cycle 1 on days 8 15 and 22 of cycle 2 then on days 1 and 15 of subsequent cycles Patients also receive teclistamab SC on days 1 3 5 15 and 22 of cycle 2 then on days 1 and 15 of subsequent cycles Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Additionally patients undergo blood sample collection throughout the trial and bone marrow aspiration and biopsy on study
After completion of study treatment patients are followed every 3 months for up to 5 years
Patients receive ST-067 subcutaneously SC on days 1 8 15 and 22 of cycle 1 on days 8 15 and 22 of cycle 2 then on days 1 and 15 of subsequent cycles Patients also receive teclistamab SC on days 1 3 5 15 and 22 of cycle 2 then on days 1 and 15 of subsequent cycles Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Additionally patients undergo blood sample collection throughout the trial and bone marrow aspiration and biopsy on study
After completion of study treatment patients are followed every 3 months for up to 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None