China-based HitGen Inc. (SHA: 688222) has announced the commencement of the first patient enrollment in a Phase II clinical study for its Category 1.1 anti-tumor drug, HG146. This study focuses on the treatment of recurrent or metastatic adenoid cystic carcinoma, a rare and aggressive form of cancer.
HG146: A Promising Small Molecule HDAC Inhibitor
HG146, a small molecule histone deacetylase (HDAC) I/IIb inhibitor, has been granted clearance for studies in multiple myeloma and advanced solid tumors or lymphomas in April 2018 and April 2021, respectively. This Phase II study represents a significant step forward in the development of HG146 as a potential treatment for cancer patients.
Positive Outcomes from Phase I Study
The concluded Phase I study has demonstrated the safety, tolerability, and preliminary efficacy of HG146, along with its pharmacokinetics. This study was crucial in determining the recommended Phase II dosage (RP2D), which will guide the dosing strategy for the current Phase II clinical trial. The positive results from the Phase I study provide a solid foundation for the ongoing Phase II study, which aims to further evaluate the drug’s efficacy and safety in a larger patient population.-Fineline Info & Tech
