A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM)

Active:	No
Cancer Type:	Multiple Myeloma Plasma cell neoplasm	NCT ID:	NCT04776018
Trial Phases:	Phase I Phase II	Protocol IDs:	TAK-981-1503 (primary)
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Takeda
NCI Full Details:	http://clinicaltrials.gov/show/NCT04776018

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.