AO-176 in Multiple Solid Tumor Malignancies

Status:	Recruiting
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	3/30/2019
Start Date:	February 4, 2019
End Date:	July 2021
Contact:	Liz Wieland, MA
Email:	ewieland@archoncology.com
Phone:	8052085232

A Phase 1 Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of AO-176

This is a first-in-human, Phase 1 multi-center, open-label, dose escalation and expansion
study of AO-176 which will evaluate the safety, tolerability, pharmacokinetics (PK),
pharmacodynamics, and clinical effects of AO-176.

This study will examine AO-176 monotherapy in patients with select advanced solid tumors for
which standard therapy proven to provide clinical benefit does not exist or is no longer
effective.

The study utilizes a classic 3+3 design, with enrollment of 3 patients per cohort and
expansion of the cohort in the event of a DLT. There will be up to 30 patients treated during
dose escalation.

Once the MTD/RP2D has been established, tumor-specific dose expansion cohorts will be
recruited to further assess safety and evaluate preliminary efficacy of AO-176.

Inclusion Criteria

1. Select advanced solid tumor for which standard therapy proven to provide clinical
benefit does not exist, or is no longer effective.

2. Measurable disease

3. ECOG status 0-1

4. Resolution of prior-therapy-related adverse effects

5. Minimum of 2 weeks since last dose of cancer therapy

Exclusion Criteria:

1. Previous hypersensitivity reaction to treatment with another monoclonal antibody.

2. Prior treatment with a Check Point Inhibitor (anti-PD-1, PD-L1, CTLA-4 etc.) within 4
weeks.

3. Prior treatment with a CD47 targeted therapy

4. Prior organ or stem cell transplant

We found this trial at

sites

University of Southern California

Los Angeles, California 90033

213) 740-2311