Study of AO-176 as Monotherapy and in Combination With Bortezomib / Dexamethasone in Relapsed / Refractory Multiple Myeloma
- 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 0-1
- Resolution of prior therapy-related adverse events
- Minimum of 2 weeks since last dose of cancer therapy or radiotherapy
- Previous Grade 3-4 infusion or hypersensitivity reaction
- Severe asthma or chronic obstructive pulmonary disease exacerbations requiring hospital admission or steroids
- Prior treatment with a checkpoint inhibitor (anti-PD-1, PD-L1 or CTLA-4) within 4 weeks.
- Prior treatment with a therapeutic agent that targets the CD47 axis.
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.
Trial Phase Phase I/II
Trial Type Treatment
- Primary ID AO-176-102
- Secondary IDs NCI-2020-11628
- Clinicaltrials.gov ID NCT04445701