Chengdu Easton Biopharmaceuticals Co.,Ltd. (688513.SH) has announced that its majority-owned subsidiary, Shanghai Chaoyang Pharmaceutical Co., Ltd., has commenced a Phase I/II clinical trial for its independently developed chemical drug, HP-002 tablets. The trial is targeting relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL), and the first patient has been enrolled and dosed.

HP-002 is a next-generation protein degradation targeting chimera (PROTAC) molecule designed to penetrate the brain and target Bruton tyrosine kinase (BTK). In preclinical studies, it has demonstrated potent anti-proliferative activity against various BTK mutant cell lines.

The primary objective of Phase I is to evaluate the safety and tolerability of HP-002 in patients with relapsed or refractory B-NHL during the dose-escalation phase. This stage aims to establish the maximum tolerated dose and determine the recommended dose for Phase II trials. Additionally, it will assess the pharmacokinetics (PK), pharmacodynamics (PD), preliminary anti-tumor activity, and disease-related biomarkers of HP-002 in B-NHL patients.

The primary objective of Phase II is to evaluate the preliminary efficacy of HP-002 in B-NHL patients during the dose-expansion phase. This phase will also assess its safety, tolerability, PK, and PD characteristics, along with efficacy-related biomarkers and cerebrospinal fluid PK profiles.

As of the date of this announcement, the first patient has been enrolled and dosed in the Phase I dose-escalation stage of the study.