Multiple Myeloma Clinical Trial

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

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).

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Full 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 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.

View Eligibility Criteria

Eligibility Criteria

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

Key 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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

157

Study ID:

NCT04445701

Recruitment Status:

Active, not recruiting

Sponsor:

Arch Oncology

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There are 6 Locations for this study

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Mayo Clinic
Phoenix Arizona, 85054, United States
Mayo Clinic
Jacksonville Florida, 32224, United States
Emory University
Atlanta Georgia, 30322, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Medical College of Wisconsin and Froedtert Hospital
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

157

Study ID:

NCT04445701

Recruitment Status:

Active, not recruiting

Sponsor:


Arch Oncology

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