Delving into the Latest Updates on AU-409 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target-

Mechanism-

Therapeutic Areas

NeoplasmsDigestive System DisordersOther Diseases

Active Indication

Advanced Bile Duct CarcinomaAdvanced Hepatocellular CarcinomaAdvanced Malignant Solid Neoplasm+ [3]

Inactive Indication-

Originator Organization

Auransa, Inc.Startup

Active Organization

University of Southern California

National Cancer Institute

Auransa, Inc.Startup

+ [1]

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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This study is a Phase I, dose-escalation study of AU409 in advanced hepatocellular carcinoma patients who failed standard treatment. A '3+3' dose-escalation design will be utilized to gradually increase the dose of AU409, aiming to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor efficacy of multi-dose AU409 in patients with advanced HCC.

Start Date12 Apr 2024

Sponsor / Collaborator

Lee's Pharmaceutical Holdings Ltd.

NCT05791448

/ RecruitingPhase 1IIT

First in Human Dose Escalation Study of AU409 in Patients With Advanced Primary Liver Cancers or Advanced Solid Tumor With Liver Predominant Metastatic Disease

This phase I trial tests the safety, side effects, and best dose of a new intervention, AU409, in treating patients with primary liver cancers that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or advanced solid tumors that have spread to the liver (liver metastatic disease). AU409 may stop cancer from growing and spreading. This trial may help researchers determine if AU409 is safe and effective in treating patients with liver cancers and solid tumors with liver metastatic disease.

Start Date29 Mar 2023

Sponsor / Collaborator

University of Southern California

[+2]

100 Clinical Results associated with AU-409

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100 Translational Medicine associated with AU-409

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100 Patents (Medical) associated with AU-409

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100 Deals associated with AU-409

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Bile Duct Carcinoma	Phase 1	US	University of Southern California	29 Mar 2023
Advanced Bile Duct Carcinoma	Phase 1	US	National Cancer Institute	29 Mar 2023
Advanced Bile Duct Carcinoma	Phase 1	US	Auransa, Inc.Startup	29 Mar 2023
Advanced Malignant Solid Neoplasm	Phase 1	US	Auransa, Inc.Startup	29 Mar 2023
Primary Malignant Liver Neoplasm	Phase 1	US	University of Southern California	29 Mar 2023
Primary Malignant Liver Neoplasm	Phase 1	US	National Cancer Institute	29 Mar 2023
Primary Malignant Liver Neoplasm	Phase 1	US	Auransa, Inc.Startup	29 Mar 2023
Refractory Malignant Solid Neoplasm	Phase 1	US	University of Southern California	29 Mar 2023
Refractory Malignant Solid Neoplasm	Phase 1	US	Auransa, Inc.Startup	29 Mar 2023
Refractory Malignant Solid Neoplasm	Phase 1	US	National Cancer Institute	29 Mar 2023