BIO-106 / BiOneCure - LARVOL DELTA

BiOneCure Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for BIO-106, a Novel TROP2 ADC for the Treatment of Advanced Solid Tumors (PRNewswire) - "BiOneCure Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the IND for BIO-106, an antibody-drug conjugate (ADC) designed to target TROP-2 to treat a broad range of advanced solid tumors....The clinical study cleared by the FDA, known as StarBridge-1, is a Phase I/II, multicenter, open-label study to evaluate the safety, pharmacokinetics and preliminary anti-tumor activity of BIO-106 as monotherapy and in combination with pembrolizumab in patients with advanced cancers."

IND • Oncology • Solid Tumor

A Phase 1/2 Study in Patients With Advanced Cancers (clinicaltrials.gov) - P1/2 | N=332 | Recruiting | Sponsor: BiOneCure Therapeutics Inc.

Combination therapy • Monotherapy • New P1/2 trial • Oncology • Solid Tumor