Sutro Biopharma has dosed the first patient in a Phase I clinical trial of anti-folate receptor alpha (FoIRα) antibody-drug conjugate (ADC) STRO-002 to treat patients with ovarian and endometrial cancers.
This is the second product candidate to be evaluated resulting from Sutro’s XpressCF+ technology platform, which initially led to the discovery of STRO-001.
In April last year, Sutro started dosing patients in a Phase I clinical trial of STRO-001 to treat lymphoma and multiple myeloma.
The multi-centre, open-label, dose-escalation with dose expansion Phase I trial will evaluate the safety, tolerability and preliminary anti-tumour activity of STRO-002.
As part of the study, up to 160 women with advanced relapsed and / or progressive ovarian, fallopian, primary peritoneal or endometrial cancer will be enrolled.
Sutro Biopharma CEO Bill Newell said: “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.
“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.”
In preclinical studies, STRO-002 demonstrated potent in vitro cytotoxicity in ovarian cancer cell lines and inhibited tumour growth in multiple ovarian cancer xenograft models.
Safety studies conducted in non-human primates showed that STRO-002 was well tolerated at clinically relevant doses.
The Phase I study will comprise dose-escalation followed by dose-expansion, as part of which STRO-002 will be dosed as an intravenous infusion on day one of 21-day cycles.
Sutro developed STRO-002 using proprietary cell-free protein synthesis and site-specific conjugation platforms.