Study of AO-176 as Monotherapy and in Combination With Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma
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What's the purpose of this trial?

An open-label, multicenter, dose escalation study to evaluate the safety, tolerability and PK/pharmacodynamics of AO-176 in adults with relapsed/refractory multiple myeloma whose disease has progressed following at least 3 prior systemic lines of treatment and must have progressed on the final line of therapy received before being considered for this study. The study will be conducted in 2 phases; Phase 1 is an ascending-dose study of AO-176 monotherapy utilizing the classic 3+3 design, with enrollment of 3 patients per cohort and expansion of the cohort in the event of a dose-limiting toxicity (DLT). Following the dose escalation portion and determination of the monotherapy recommended phase 2 dose (RP2D), an ascending dose escalation study of AO-176 and dexamethasone combined with bortezomib will be evaluated utilizing the same 3+3 dose escalation design. Phase 2 will evaluate the clinical activity of AO-176 plus dexamethasone and bortezomib at the RP2D as determined in Phase 1 Part 2.

This trial has temporarily put patient recruitment on hold.


Additional Trial Information

Phase 1/2

Enrollment: 157 patients (estimated)

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Trial Locations

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Arizona

Mayo Clinic (Arizona)

Phoenix, AZ

Recruitment on Hold

Florida

Mayo Clinic (Jacksonville)

Jacksonville, FL

Recruitment on Hold

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Recruitment on Hold

Massachusetts

Beth Israel Deaconess Medical Center

Boston, MA

Not Yet Accepting

Dana-Farber Cancer Institute

Boston, MA

Not Yet Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Recruitment on Hold

Washington

Swedish - Cherry Hill Campus Cherry Hill Campus

Seattle, WA

Not Yet Accepting

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Recruitment on Hold

Trial Links

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