A Phase 1/2, Dose Escalation Safety and Tolerability Study of AO-176 as Monotherapy and in Combination With Bortezomib and Dexamethasone in Adults With Relapsed or Refractory Multiple Myeloma

AO-176-102

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).

2020-11-30

2022-08-05

2022-11-14

Completed

Early phase I

10

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 0-2 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Phase 1 Part 1: Up to 4 dose escalation cohorts will be enrolled; each cohort will initially recruit 3 patients to receive AO-176 monotherapy in a standard 3+3 design; the cohort will be expanded in the event of a DLT. Once the RP2D has been identified, an expansion cohort will be enrolled to evaluate AO-176 at the RP2D in combination with dexamethasone (DEX).\n\nPhase 1 Part 2: Dose escalation cohorts will evaluate AO-176 in combination with DEX and bortezomib (BORT) to determine the RP2D of AO-176 + DEX + BORT in a standard 3+3 design; the cohort will be expanded in the event of a DLT.\n\nPhase 2: Up to 48 patients will be enrolled to evaluate the preliminary efficacy of AO-176 + DEX + BORT using a Simon 2-stage design.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}

2023-08-22