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

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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
3
sites
Los Angeles, California 90033
213) 740-2311
Principal Investigator: Anthony El-Khoueriy, MD
University of Southern California The University of Southern California is one of the world’s leading...
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Principal Investigator: Alex Spira, MD
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Phone: 615-339-4214
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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