Status:
COMPLETED
Study of AO-176 as Monotherapy and in Combination With Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
Arch Oncology
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 b...
Detailed Description
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 progresse...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
November 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04445701
Start Date
November 30 2020
End Date
November 14 2022
Last Update
August 22 2023
Active Locations (6)
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1
Mayo Clinic
Phoenix, Arizona, United States, 85054
2
Mayo Clinic
Jacksonville, Florida, United States, 32224
3
Emory University
Atlanta, Georgia, United States, 30322
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215