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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04776018.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer InstituteStatus: Active
Contact: Sagar Lonial
Phone: 404-778-1900
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.
Lead OrganizationTakeda USA Inc