NEW YORK – Byondis said Thursday that the first patients with MET-positive solid tumors received its antibody-drug conjugant BYON3521 in a Phase I trial.
The Nijmegen, Netherlands-based firm will enroll up to 150 patients with c-MET-expressing, MET-amplified, or MET-mutated locally advanced or metastatic solid tumors. Patients must have progressed on standard therapy or have no existing therapy option to partake in the trial. Patients with MET exon 14-mutated tumors will be excluded from the study, the firm added.
In the first dose-escalation part of the trial, Byondis will evaluate BYON3521's safety and maximum tolerated dose in 30 patients and settle on a recommended dose to use in the expansion portion of the trial. In that second part, up to 120 patients with renal cell cancer, uveal melanoma, head and neck squamous cell cancer, and other tumors will receive the recommended BYON3521 dose. Researchers will track patients' objective response rate and safety.
According to Byondis, BYON3521 has shown activity against c-MET-expressing tumors and a favorable safety profile in preclinical studies.
In addition to BYON3521, Byondis is investigating another antibody-drug conjugate, SYD985, in a Phase II trial involving patients with HER2-expressing recurrent, advanced, or metastatic endometrial cancer. The company has also submitted a biologics license application for SYD985 to the US Food and Drug Administration and a marketing authorization application to the European Medicines Agency for advanced HER2-positive breast cancer.