HB0052 / Zhejiang Huahai Pharma - LARVOL DELTA

A Study to Evaluate the Safety and Efficacy of HB0052 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=30 | Enrolling by invitation | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.

New P1/2 trial • Solid Tumor

The first patient was completed in the Phase I clinical trial of Huaotai's independently developed CD73-targeted antibody-drug conjugate (ADC)... [Google translation] (Sohu.com) - "Recently, Shanghai Huaotai Biopharmaceutical Co., Ltd...announced that the third-generation antibody-drug conjugate (ADC) project HB0052...has successfully entered the Phase I clinical trial stage and completed the enrollment and dosing of the first subject at Shandong Cancer Hospital on September 4, 2024....This clinical study is led by Professor Shen Lin of Peking University Cancer Hospital. The main purpose is to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of HB0052 in the treatment of advanced solid tumor subjects. It is planned to be used to treat patients with advanced pancreatic cancer, advanced hepatocellular carcinoma, advanced gastric and gastroesophageal junction adenocarcinoma and other advanced solid tumors. Phase I is planned to be carried out in 7 clinical centers in China, and Phase IIa is planned to be carried out in 15-20 centers in China."

Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Pancreatic Cancer • Solid Tumor

This week’s domestic/global innovative drug IND, NDA, approved marketing and phase III clinical summary [Google translation] (163.com) - "On February 22, Huaotai Biotechnology's clinical trial application for HB0052 for injection was accepted by CDE. HB0052 is a CD73-targeted. ADC that uses topoisomerase inhibitors as a payload."

New trial • Oncology • Solid Tumor

Huahai Pharmaceutical: Subsidiary's HB0052 for injection obtained drug clinical trial license [Google translation] (Eastmoney.com) - "...Huahai Pharmaceutical. According to an announcement, recently, the company’s subsidiary Shanghai Huaotai Biotechnology Pharmaceutical Co., Ltd....has received approval from the U.S. Food and Drug Administration (hereinafter referred to as 'U.S. FDA') for a new drug clinical trial (IND) application for HB0052 for injection for advanced solid tumors."

IND • Oncology • Solid Tumor