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Ambrx Begins Phase I Trial of ARX517 in PSMA-Expressing Tumors

NEW YORK – Ambrx said on Tuesday it has dosed the first patient in a Phase I trial of its product candidate ARX517 in PSMA-expressing advanced solid tumors.

The trial, called APEX-01, will have a dose escalation stage and a dose expansion phase and enroll up to 76 patients with advanced solid tumors who have failed prior standard therapies. Researchers will evaluate the safety, tolerability, pharmacokinetic, and anti-tumor activity of ARX517, and evaluate six dose levels of the drug to determine the recommended Phase II dose.

"ARX517 is the second [antibody drug conjugate] in our internal pipeline to enter the clinic, which I believe speaks to the broad applicability and productivity of our technology platform," Ambrx CEO Feng Tian said in a statement.

La Jolla, California-based Ambrx is also developing the anti-HER2 antibody drug conjugate, ARX788, which it is studying in HER2-positive breast cancer, gastric cancer, and other solid tumors. Earlier this year, the US Food and Drug Administration granted orphan drug designation to ARX788 for the treatment of HER2-positive gastric cancer. The FDA also granted fast track designation to ARX788 this year for advanced or metastatic HER2-positive breast cancer.

In addition to ARX517 and ARX788, the company is also developing a drug targeting CD70 and has four other agents in preclinical research.