Clinical trial · Interventional
Study of AO-176 as Monotherapy and in Combination With Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma
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
NCT04445701CI-TRIAL-00068996completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AO-176 | Drug | — | UNRESOLVED |
| AO-176 + Dex | Drug | — | UNRESOLVED |
| AO-176 + Dex + Bort | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- AO-176 Dose Escalation Monotherapy
- description
- The dose escalation monotherapy cohorts will initially recruit 3 patients to receive AO-176 in a standard 3+3 design; cohorts will be expanded in the event of a DLT.
- interventionNames
- Drug: AO-176
- type
- EXPERIMENTAL
- label
- AO-176 + DEX Expansion Cohort
- description
- Once the monotherapy RP2D has been established, an expansion cohort of AO-176 + dexamethasone will be enrolled.
- interventionNames
- Drug: AO-176 + Dex
- type
- EXPERIMENTAL
- label
- AO-176 + DEX + BORT Dose Escalation
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDAndrejeva G, Capoccia BJ, Hiebsch RR, Donio MJ, Darwech IM, Puro RJ, Pereira DS. Novel SIRPalpha Antibodies That Induce Single-Agent Phagocytosis of Tumor Cells while Preserving T Cells. J Immunol. 2021 Feb 15;206(4):712-721. doi: 10.4049/jimmunol.2001019. Epub 2021 Jan 11. PMID 33431660