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

Verified

Overview

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 102 Patients
Treatments
Tags
Trial Sponsors
  • Arch Oncology
NCT Identifier

NCT04445701

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.

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Mayo Clinic (Arizona)
Mayo Clinic (Jacksonville)
Mayo Clinic (Jacksonville)

Jacksonville, FL

Mayo Clinic (Rochester)
Mayo Clinic (Rochester)

Rochester, MN

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Swedish Cancer Institute Cherry Hill Campus
Arizona
Mayo Clinic (Arizona)
Florida
Mayo Clinic (Jacksonville)
Mayo Clinic (Jacksonville)

Jacksonville, FL

Georgia
Winship Cancer Institute of Emory University
Massachusetts
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Minnesota
Mayo Clinic (Rochester)
Mayo Clinic (Rochester)

Rochester, MN

Washington
Swedish Cancer Institute Cherry Hill Campus
Wisconsin
Medical College of Wisconsin Froedtert Hospital

Resources

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