Study of AO-176 as Monotherapy and in Combination With Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring AO-176, CD47, Immunotherapy, Monoclonal antibody
Eligibility Criteria
Key Inclusion Criteria:
- 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 Exclusion Criteria:
- 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.
Sites / Locations
- Mayo Clinic
- Mayo Clinic
- Emory University
- Dana-Farber Cancer Institute
- Mayo Clinic
- Medical College of Wisconsin and Froedtert Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
AO-176 Dose Escalation Monotherapy
AO-176 + DEX Expansion Cohort
AO-176 + DEX + BORT Dose Escalation
The dose escalation monotherapy cohorts will initially recruit 3 patients to receive AO-176 in a standard 3+3 design; cohorts will be expanded in the event of a DLT.
Once the monotherapy RP2D has been established, an expansion cohort of AO-176 + dexamethasone will be enrolled.
Following evaluation of AO-176 + dexamethasone, dose escalation cohorts of AO-176 + dexamethasone + bortezomib will be enrolled. Each dose escalation cohort will initially recruit 3 patients in a standard 3+3 design; cohorts will be expanded in the event of a DLT. The Phase 2 portion of the study will further evaluate the RP2D of AO-176 + DEX + BORT.