Sutro Biopharma has dosed the first patient in a Phase I study of STRO-002, an anti-folate receptor alpha (FoIRα) antibody-drug conjugate (ADC), in patients with ovarian and endometrial cancers. This is the second product candidate to be evaluated in clinical trials resulting from Sutro's XpressCF+™ technology platform.
The study is a multi-center, open-label, dose-escalation with dose expansion Phase I trial evaluating the safety, tolerability and preliminary anti-tumor activity of STRO-002. The study plans to enroll up to 160 women with advanced relapsed and/or progressive ovarian, fallopian, primary peritoneal or endometrial cancer.
"Moving our second product candidate into human clinical trials is another momentous milestone in Sutro's evolution from a technology platform company to a clinical stage company," said Sutro CEO Bill Newell. "Our goal is to ultimately help fill the unmet need for more targeted therapies for patients with ovarian and endometrial cancer and advancing STRO-002 into the clinic brings us one step closer to achieving this."
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
STRO-002 is designed to target FoIRα, a cell-surface protein highly expressed in ovarian cancer. In preclinical studies, STRO-002 demonstrated potent in vitro cytotoxicity in ovarian cancer cell lines and significantly inhibited tumor growth in multiple ovarian cancer xenograft models. In safety studies conducted in non-human primates, STRO-002 was well tolerated at clinically relevant doses. "Based on observations from pre-clinical studies, STRO-002 has the potential to overcome traditional dose-limiting factors in the clinical setting, including ocular toxicity, which is a vexing problem with some ADCs," said Sutro Chief Medical Officer, Arturo Molina, M.D.
"Sutro's unique ADC has the potential to be another important therapeutic option for oncologists in treating patients with ovarian and endometrial cancer. We look forward to evaluating the next-generation of ADCs in this study," Denise Uyar, M.D., Associate Professor of Gynecology Oncology at Medical College of Wisconsin, an investigator in the STRO-002 study said.
The Phase I study will consist of two parts: dose-escalation followed by dose-expansion. In both parts of the study, STRO-002 will be dosed as an intravenous infusion on Day 1 of 21-day cycles.
STRO-002 was developed using Sutro's proprietary cell-free protein synthesis and site-specific conjugation platforms, which facilitates precision design and rapid empirical optimization of ADCs and other product candidates.