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

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arch Oncology

Criteria

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.