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Anti-tumor antibiotic

AO-176 for Multiple Myeloma

Phase 1 & 2

Waitlist Available

Research Sponsored by Arch Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is testing a new drug for safety, side effects, and how well it works in adults with multiple myeloma who have relapsed or are refractory to other treatments.

Eligible Conditions

Multiple Myeloma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1: MTD / RP2D of AO-176 assessed by incidence of dose-limiting toxicities and incidence of treatment-related adverse events (TEAEs) as assessed by CTCAE v5.0

Phase 2: Objective response rate (ORR) of AO-176 + DEX + BORT

Secondary outcome measures

Phase 1: Disease control rate (DCR) of single agent AO-176

Phase 1: Duration of response (DOR) of single agent AO-176

Phase 1: ORR of single agent AO-176

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: AO-176 Dose Escalation MonotherapyExperimental Treatment1 Intervention

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.

Group II: AO-176 + DEX Expansion CohortExperimental Treatment1 Intervention

Once the monotherapy RP2D has been established, an expansion cohort of AO-176 + dexamethasone will be enrolled.

Group III: AO-176 + DEX + BORT Dose EscalationExperimental Treatment1 Intervention

Following evaluation of AO-176 + dexamethasone, dose escalation cohorts of AO-176 + dexamethasone + bortezomib will be enrolled. Each dose escalation cohort will initially recruit 3 patients in a standard 3+3 design; cohorts will be expanded in the event of a DLT. The Phase 2 portion of the study will further evaluate the RP2D of AO-176 + DEX + BORT.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AO-176 + Dex + Bort

2020

Completed Phase 2

~10

AO-176

2019

Completed Phase 2

~70

AO-176 + Dex

2020

Completed Phase 2

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Arch OncologyLead Sponsor

1 Previous Clinical Trials

57 Total Patients Enrolled

Naimish Pandya, MDStudy DirectorMedical Monitor

1 Previous Clinical Trials

87 Total Patients Enrolled

Ben Oshrine, MDStudy DirectorSr Medical Director, Arch Oncology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study looking for new participants at the moment?

"The clinical trial was posted on 11/30/2020 and updated on 8/3/2022, which suggests that the team is no longer actively recruiting patients. Although this study has completed patient recruitment, there are still 827 other trials underway that need participants."

Answered by AI

Where can people go to participate in this trial?

"There are a total of eight different clinical trial sites that are enrolling patients. A few notable locations include the Mayo Clinic in Phoenix, Emory University in Atlanta, and Dana-Farber Cancer Institute in Milwaukee."

Answered by AI

What are the primary goals of this research project?

"The primary aims of this study, which will follow patients for around 12 months, are to Phase 1: establish the maximum tolerated dose / recommended phase 2 dose of AO-176 by measuring incidence of dose-limiting toxicities and treatment-related adverse events (as assessed by CTCAE v5.0), and in Phase 2: assess the overall survival rate of AO-176 + DEX + BORT combination therapy. Additionally, investigators will also look at secondary objectives including disease control rates inPhase 1 among single agent AO-176 patients as well as progression free survival in Phase 2 among participants receiving AO-176"

Answered by AI

Recent research and studies

The Journal of ImmunologyJournal

Novel Sirpα Antibodies That Induce Single-agent Phagocytosis of Tumor Cells While Preserving T Cells

Andrejeva, Gabriela, Benjamin J. Capoccia, Ronald R. Hiebsch, Michael J. Donio, Isra M. Darwech, Robyn J. Puro, and Daniel S. Pereira. 2021. “Novel Sirpα Antibodies That Induce Single-agent Phagocytosis of Tumor Cells While Preserving T Cells”. The Journal of Immunology. The American Association of Immunologists. doi:10.4049/jimmunol.2001019.

clinicaltrials.govStudy

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

2020. "Study of AO-176 as Monotherapy and in Combination With Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04445701.