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

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Arch Oncology

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Research Team

Ben Oshrine, MD

Principal Investigator

Sr Medical Director, Arch Oncology

Eligibility Criteria

Inclusion Criteria

You have tried and not responded to at least three different treatments for multiple myeloma.

Confirmed diagnosis of symptomatic MM per IMWG criteria

Measurable disease

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Exclusion Criteria

Prior treatment with a checkpoint inhibitor (anti-PD-1, PD-L1 or CTLA-4) within 4 weeks

You have had a severe allergic reaction or bad side effects from a previous infusion.

You have experienced severe asthma or chronic obstructive pulmonary disease (COPD) flare-ups that have required hospitalization or treatment with steroids.

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Treatment Details

Interventions

AO-176 (Anti-tumor antibiotic)
Bortezomib (Proteasome Inhibitor)
Dexamethasone (Corticosteroid)

Participant Groups

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.