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

NOT ENROLLING
Protocol # :
20-322
Conditions
Multiple Myeloma
Phase
I/II
Disease Sites
Multiple Myeloma
Principal Investigator
Mo, Clifton, C.
Site Research Nurses
Babcock, Elise
Bright, Susan
Knudsen, Elisabeth
Marzullo, Tess, V.
Tichon, Jennifer

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.

20-322