Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04776018
Status:
TERMINATED
Last Update Posted:
2024-01-05
First Post:
2021-02-25
Brief Title:
A Study Of TAK-981 Given With Monoclonal Antibodies mAbs In Adults With Relapsed or Refractory Multiple Myeloma RRMM
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 1b2 Open-Label Multicenter Study to Evaluate the Safety and Efficacy of TAK-981 in Combination With Monoclonal Antibodies in Adult Patients With Relapsed andor Refractory Multiple Myeloma
Status:
TERMINATED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business Reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
TAK-981 is being tested in combination with anti-CD38 monoclonal antibodies mAbs to treat participants who have relapsed or refractory multiple myeloma RRMM
The main aims of the study are to evaluate the safety and efficacy of TAK-981 in combination with anti-CD38 mAbs and to determine the recommended Phase 2 dose RP2D
Participants will be on this combination treatment for 28-day cycles They will continue with this treatment until disease progression or unacceptable toxicity
The main aims of the study are to evaluate the safety and efficacy of TAK-981 in combination with anti-CD38 mAbs and to determine the recommended Phase 2 dose RP2D
Participants will be on this combination treatment for 28-day cycles They will continue with this treatment until disease progression or unacceptable toxicity
Detailed Description:
The drug being tested in this study is called TAK-981 TAK-981 in combination with an anti-CD38 monoclonal antibody mAbs is being tested to treat people who have RRMM The study will include a dose escalation phase and a dose expansion phase
The study will enroll approximately 81 participants approximately 30 participants in the dose escalation phase Part 1 approximately 15 participants in Part 2 and up to 36 participants in dose expansion phase Part 2 Participants will receive escalating doses of TAK-981 in combination with fixed doses as follows
Phase 1b Part 1 - Dose Escalation Arm A - TAK-981 Twice Weekly BIW Mezagitamab
Phase 1b Part 1 - Dose Escalation Arm B - TAK-981 Weekly QW Mezagitamab
Phase 1b Part 2 - Dose Escalation TAK-981 Daratumumab and Hyaluronidase-fihj
Once RP2D is determined in Phase 1 participants with RRMM will be enrolled in Phase 2
Phase 2 - Dose Expansion TAK-981 Daratumumab and Hyaluronidase-fihj or Mezagitamab
This multi-center trial will be conducted in North America The overall time to participate in this study is 2 years Participants will make multiple visits to the clinic and progression-free survival follow-up for maximum up to 12 months after last dose of study drug
The study will enroll approximately 81 participants approximately 30 participants in the dose escalation phase Part 1 approximately 15 participants in Part 2 and up to 36 participants in dose expansion phase Part 2 Participants will receive escalating doses of TAK-981 in combination with fixed doses as follows
Phase 1b Part 1 - Dose Escalation Arm A - TAK-981 Twice Weekly BIW Mezagitamab
Phase 1b Part 1 - Dose Escalation Arm B - TAK-981 Weekly QW Mezagitamab
Phase 1b Part 2 - Dose Escalation TAK-981 Daratumumab and Hyaluronidase-fihj
Once RP2D is determined in Phase 1 participants with RRMM will be enrolled in Phase 2
Phase 2 - Dose Expansion TAK-981 Daratumumab and Hyaluronidase-fihj or Mezagitamab
This multi-center trial will be conducted in North America The overall time to participate in this study is 2 years Participants will make multiple visits to the clinic and progression-free survival follow-up for maximum up to 12 months after last dose of study drug
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?:
True
Is an FDA AA801 Violation?:
None