Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its next-generation CD73 inhibitor, ABSK051, in China. This first-in-human (FIH), multi-center, open-label study will evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and preliminary anti-tumor activity of ABSK051 in patients with advanced solid tumors.
Study Design and Combination Therapy
The Phase I study is designed to include two phases: monotherapy dosage escalation and combination therapy dosage escalation. In addition to assessing ABSK051 as a monotherapy, the study will also evaluate the molecule in combination with BeiGene’s (NASDAQ: BGNE) programmed death-1 (PD-1) inhibitor, tislelizumab, in specific tumor types, including lung cancer, colorectal cancer, ovarian cancer, and pancreatic ductal adenocarcinoma.
Pharmacological Data and Preclinical Safety
In vitro and in vivo pharmacological data have demonstrated that ABSK051 possesses strong efficacy and selectivity against CD73, exhibiting significant anti-tumor effects. Furthermore, the toxicity profile of ABSK051 has been thoroughly characterized in preclinical safety assessment studies, indicating its potential for safe use in clinical settings.- Flcube.com
