Clinical Trials

Ambrx, along with its partners, is evaluating Engineered Precision Biologics in clinical trials around the world, including trials for its antibody drug conjugates in the United States.

Active Studies in the United States

ACE-PAN-TUMOR-01

We are enrolling an open-label dose-escalation study on the effectiveness of ARX-788 in patients with advanced cancers with HER2 expression. ARX788 is a conjugate of a HER2 targeted antibody with two cytotoxic payloads site-specifically conjugated. It is designed to form a highly stable covalent bond and kill tuor cells only upon entry into the cell – potentially limiting effects on health tissue.

Phase 1a of this study is designed to determine the recommended dose for Phase 2 in subjects with advanced cancer whose HER2 test results are positive. Phase 1b is designed to assess anticancer activity and safety in 2 advanced breast cancer expansion cohorts.

We are currently recruiting patients in California, Missouri, Ohio, and Texas in the United States, as well as New South Wales, Queensland and Victoria in Australia.

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USC Norris Cancer Hospital – Recruiting
Los Angeles, California, United States, 90033

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UCLA Hematology-Oncology – Recruiting
Santa Monica, California, United States, 90095

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Washington University School of Medicine – Recruiting
Saint Louis, Missouri, United States, 63110

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Cleveland Clinic – Recruiting
Cleveland, Ohio, United States, 44195

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Baylor Sammons Cancer Center – Recruiting
Dallas, Texas, United States, 75246

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Albury Wodonga University Hospital – Recruiting
East Albury, New South Wales, Australia, 2640

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Mater Misericordiae Limited – Recruiting
South Brisbane, Queensland, Australia, 4101

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Princess Alexandria Hospital – Recruiting
Woolloongabba, Queensland, Australia, 4102

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Monash Health – Recruiting
Clayton, Victoria, Australia, 3168

For more information, please visit clinicaltrials.gov.

Expanded Access Program

At Ambrx, we are committed to developing products that bring new, innovative therapies to patients, such as ARX788.

At this time, Ambrx does not offer an expanded access program and is not accepting expanded access requests for investigational products, such as ARX788. Ambrx’ current focus and priority is to complete the product development program for its investigational product(s), such as ARX788, to obtain the required safety and efficacy data needed for regulatory approval. We believe that focusing our resources on our clinical trial programs is the best path forward to bring our investigational product(s) to patients as quickly and safely as possible. Patients can gain access to our investigational product(s), such as ARX788, by participating in our clinical trials. If you would like to learn more about Ambrx’ clinical trials, please view www.clinicaltrials.gov.

If you have additional questions about Ambrx’ expanded access policy, please email us at expanded.access@ambrx.com.

As we continue to develop investigational product(s), we will review our expanded access policy for investigational product(s) and may make updates to this policy. For more information about expanded access in the U.S., please visit the FDA website at https://www.fda.gov/newsevents/public-health-focus/expanded-access.