AO-176 in Multiple Solid Tumor Malignancies
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ClinicalTrials.gov Identifier: NCT03834948 |
Recruitment Status :
Recruiting
First Posted : February 8, 2019
Last Update Posted : September 21, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumor | Drug: AO-176 Drug: AO-176 + Paclitaxel | Phase 1 Phase 2 |
This is a first-in-human, Phase 1/2 multicenter, open-label, dose escalation and expansion study of AO-176 in patients with solid tumors. Part A of this study will examine escalating repeat doses of AO-176 monotherapy in patients with select advanced solid tumors, including epithelial ovarian carcinoma (EOC), which will include primary peritoneal and fallopian tube carcinoma; squamous cell carcinoma of the head and neck; endometrial carcinoma; castration resistant prostate cancer; non-small cell lung adenocarcinoma; papillary thyroid carcinoma; pleural or peritoneal malignant mesothelioma; and gastroesophageal adenocarcinoma, for which standard therapy proven to provide clinical benefit does not exist or is no longer effective.
Part B of this study will examine escalating repeat doses of AO-176 in combination with paclitaxel in platinum-resistant EOC, including primary peritoneal and fallopian tube carcinoma; endometrial carcinoma; and gastric adenocarcinoma/gastroesophageal adenocarcinoma.
The monotherapy and combination Dose Escalation portions of the study utilize a classic 3+3 design, with enrollment of 3 patients per cohort and expansion of the cohort in the event of a dose-limiting toxicity (DLT).
Once the maximum-tolerated dose (MTD)/recommended phase 2 dose (RP2D) has been established in dose escalation, tumor-specific dose expansion cohorts will be recruited to further assess safety and evaluate preliminary efficacy of AO-176 as monotherapy and in combination with paclitaxel.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 132 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | Each dose escalation cohort will initially recruit 3 patients to receive AO-176 or AO-176 + paclitaxel in a standard 3+3 design; the cohort will be expanded in the event of a DLT. Once the MTD/RP2D has been established for monotherapy or for AO-176 + paclitaxel, tumor-specific dose expansion cohorts will be recruited to further assess safety and evaluate preliminary efficacy. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/2 Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AO-176 |
Actual Study Start Date : | February 4, 2019 |
Estimated Primary Completion Date : | April 2021 |
Estimated Study Completion Date : | July 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: AO-176 Dose Escalation
Each dose escalation cohort 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.
|
Drug: AO-176
Humanized monoclonal antibody (mAb) targeting CD47 |
Experimental: AO-176 Dose Expansion
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.
|
Drug: AO-176
Humanized monoclonal antibody (mAb) targeting CD47 |
Experimental: AO-176 + Paclitaxel Dose Escalation
Each dose escalation cohort will initially recruit 3 patients to receive AO-176 and paclitaxel in a standard 3+3 design; cohorts will be expanded in the event of a DLT.
|
Drug: AO-176 + Paclitaxel
Humanized monoclonal antibody (mAb) targeting CD47 and paclitaxel |
Experimental: AO-176 + Paclitaxel Dose Expansion
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 + paclitaxel.
|
Drug: AO-176 + Paclitaxel
Humanized monoclonal antibody (mAb) targeting CD47 and paclitaxel |
- Safety of AO-176 assessed by adverse events and laboratory abnormalities [ Time Frame: Up to 12 months ]Evaluate the safety of AO-176 measured by the number adverse events, serious adverse events and lab abnormalities.
- Safety of AO-176 and paclitaxel assessed by adverse events and laboratory abnormalities [ Time Frame: Up to 12 months ]Evaluate the safety of AO-176 in combination with paclitaxel measured by the number adverse events, serious adverse events and lab abnormalities.
- AO-176 Anti-Tumor Activity assessed by changes in response criteria [ Time Frame: Up to 12 months ]Evaluate objective response rate of AO-176 using RECIST v1.1 and iRECIST.
- AO-176 + Paclitaxel Anti-Tumor Activity assessed by changes in response criteria [ Time Frame: Up to 12 months ]Evaluate objective response rate of AO-176 in combination with paclitaxel using RECIST v1.1 and iRECIST.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria
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Select advanced solid tumor for which standard therapy proven to provide clinical benefit does not exist, or is no longer effective
Part A:
- Epithelial ovarian carcinoma (EOC)
- Endometrial carcinoma
- Castration resistant prostate cancer
- Non-small cell lung adenocarcinoma
- Papillary thyroid carcinoma
- Malignant mesothelioma (pleural or peritoneal)
- Gastroesophageal adenocarcinoma
- Squamous cell carcinoma of the head and neck
Part B:
- Platinum-resistant EOC (including fallopian tube or primary peritoneal cancer)
- Endometrial carcinoma
- Gastric adenocarcinoma/gastroesophageal adenocarcinoma
- Measurable disease
- ECOG status 0-1
- Resolution of prior-therapy-related adverse effects
- Minimum of 3 weeks or 5 half-lives since last dose of cancer therapy
Key Exclusion Criteria:
- Previous hypersensitivity reaction to treatment with another monoclonal antibody
- Unresolved hypersensitivity to paclitaxel or any of its excipients (Part B only). Patients who have been desensitized may participate.
- Prior treatment with a checkpoint inhibitor (anti-PD-1, PD-L1, CTLA-4 etc.) within 4 weeks prior to the start of study drug
- Prior treatment with a CD47-targeted therapy
- Prior organ or stem cell transplant

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834948
Contact: Kevin Romanko, DPM | 4156714028 | kromanko@archoncology.com | |
Contact: Amy Douglas | adouglas@archoncology.com |
United States, California | |
University of Southern California | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Xiomara Menendez, RN,BSN menendez_x@med.usc.edu | |
Contact: Lorraine Martinez Lorraine.Martinez@med.usc.edu | |
Principal Investigator: Anthony El-Khoueriy, MD | |
University of California San Francisco | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Claire Hooker 415-353-7084 Claire.Hooker@ucsf.edu | |
Principal Investigator: Pamela Munster, MD | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02215-5450 | |
Contact: Christin Whalen, RN, BSN, OCN christin_whalen@dfci.harvard.edu | |
Principal Investigator: Joyce Liu, MD, MPH | |
United States, Oregon | |
Oregon Health Science University | Active, not recruiting |
Portland, Oregon, United States, 97239 | |
United States, Tennessee | |
Tennessee Oncology | Recruiting |
Nashville, Tennessee, United States, 37203 | |
Contact 615-339-4214 asksarah@sarahcannon.com | |
United States, Virginia | |
Virginia Cancer Specialists | Recruiting |
Fairfax, Virginia, United States, 22031 | |
Contact: Claudia Phillips, RN, BSN, OCN, CCRP claudia.phillips@usoncology.com | |
Principal Investigator: Alex Spira, MD |
Study Director: | Jackie Walling, MBChB, PhD | Arch Oncology |
Responsible Party: | Arch Oncology |
ClinicalTrials.gov Identifier: | NCT03834948 |
Other Study ID Numbers: |
AO-176-101 |
First Posted: | February 8, 2019 Key Record Dates |
Last Update Posted: | September 21, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
CD47 AO-176 Immunotherapy |
Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |