Study of AO-176 as Monotherapy and in Combination With Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma
18 Years and older, Male and Female
AO-176-102 (primary)
NCI-2020-11628
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.
Eligibility
- Confirmed diagnosis of symptomatic MM per IMWG criteria
- Measurable disease
- Relapsed or refractory to at least 3 prior systemic lines of therapy for MM
- Eastern Cooperative Oncology Group (ECOG) status 0-2
- Resolution of prior therapy-related adverse events
- Minimum of 2 weeks since last dose of cancer therapy or radiotherapy Key
Treatment Sites in Georgia
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