Study of AO-176 as Monotherapy and in Combination With Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma



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.

SparkCures ID 1104
Trial Phase Phase 1/2
Enrollment 10 Patients
Trial Sponsors
  • Arch Oncology
NCT Identifier


Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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 0-1
  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.

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