Delving into the Latest Updates on HH-009 with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

HH 009, HH009

Target

FGF19

Mechanism

FGF19 antagonists(Fibroblast growth factor 19 antagonists)

Therapeutic Areas

NeoplasmsDigestive System Disorders

Active Indication

Hepatocellular Carcinoma

Inactive Indication

Advanced Malignant Solid Neoplasm

Originator Organization

Huahui Health Ltd.

Active Organization

Huahui Health Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

RegulationOrphan Drug (US)

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剂量递增阶段（Ia）主要目的： 1）评估HH-009注射液治疗晚期实体瘤的安全性和耐受性； 2）确定HH-009注射液治疗晚期实体瘤受试者的最大耐受剂量（MTD）和/或剂量拓展阶段推荐剂量。剂量拓展阶段（Ib）主要目的： 3）确定HH-009注射液治疗晚期肝细胞癌（HCC）及其他实体瘤受试者的II期推荐剂量（RP2D）。

[Translation]

The main objectives of the dose escalation phase (Ia): 1) To evaluate the safety and tolerability of HH-009 injection in the treatment of advanced solid tumors; 2) To determine the maximum tolerated dose (MTD) and/or the recommended dose for the dose expansion phase of HH-009 injection in the treatment of advanced solid tumor subjects. The main objectives of the dose expansion phase (Ib): 3) To determine the Phase II recommended dose (RP2D) of HH-009 injection in the treatment of advanced hepatocellular carcinoma (HCC) and other solid tumor subjects.

Start Date02 Aug 2022

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