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

Trial Status: Active

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).

Inclusion Criteria

  • 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 0-1
  • Resolution of prior therapy-related adverse events
  • Minimum of 2 weeks since last dose of cancer therapy or radiotherapy

Exclusion Criteria

  • 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.

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: ACTIVE
Contact: Jeremy T Larsen

Florida

Jacksonville
Mayo Clinic in Florida
Status: ACTIVE
Contact: Sikander Ailawadhi

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: APPROVED

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Morie Abraham Gertz

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.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Arch Oncology

  • Primary ID AO-176-102
  • Secondary IDs NCI-2020-11628
  • Clinicaltrials.gov ID NCT04445701