A Phase 1/2, Dose Escalation Safety and Tolerability Study of AO-176 as Monotherapy and in Combination with Bortezomib and Dexamethasone in Adults with Relapsed or Refractory Multiple Myeloma
Trial Description
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).
Eligibility Requirements
Key Inclusion Criteria:
1. Confirmed diagnosis of symptomatic MM per IMWG criteria
2. Measurable disease
3. Relapsed or refractory to at least 3 prior systemic lines of therapy for MM
4. Eastern Cooperative Oncology Group (ECOG) status 0-2
5. Resolution of prior therapy-related adverse events
6. Minimum of 2 weeks since last dose of cancer therapy or radiotherapy
Key Exclusion Criteria:
1. Previous Grade 3-4 infusion or hypersensitivity reaction
2. Severe asthma or chronic obstructive pulmonary disease exacerbations requiring
hospital admission or steroids
3. Prior treatment with a checkpoint inhibitor (anti-PD-1, PD-L1 or CTLA-4) within 4
weeks.
4. Prior treatment with a therapeutic agent that targets the CD47 axis.