Study of AO-176 as Monotherapy and in Combination With Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma

Active:	No
Cancer Type:	Multiple Myeloma	NCT ID:	NCT04445701
Trial Phases:	Phase I Phase II	Protocol IDs:	AO-176-102 (primary) NCI-2020-11628
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Arch Oncology
NCI Full Details:	http://clinicaltrials.gov/show/NCT04445701

Summary

Open-label, dose escalation study to evaluate the safety, tolerability, pharmacokinetics
(PK)/pharmacodynamics and initial efficacy of AO-176 as monotherapy and in combination with
dexamethasone and bortezomib in adults with relapsed/refractory multiple myeloma (MM).

Objectives

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.

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.