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).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04445701.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer InstituteStatus: Active
Name Not Available
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.
Lead OrganizationArch Oncology
