AU409 / Auransa, Lee's Pharm - LARVOL DELTA

AU409-LEES-2021-03: Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Lee's Pharmaceutical Limited | Trial completion date: Aug 2026 ➔ Dec 2025

Trial completion date • Hepatocellular Cancer • Oncology • Solid Tumor

Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Lee's Pharmaceutical Limited

Metastases • New P1 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

AI-Biopharma Auransa Announces Successful First Patient Dosed in Phase 1 Clinical Trial for Liver Cancer - "'Despite the higher response rates seen with immunotherapy combinations, when compared to TKIs, most patients will develop resistance to treatment,' said Dr. El-Khoueiry. 'In second line treatment and beyond, TKIs like sorafenib offer limited efficacy and the potential for significant toxicity. This leaves a substantial gap for new, improved therapies for liver cancer. We look forward to seeing how the AU-409 program progresses to address these unmet patient needs.'"

Media quote

AI-Biopharma Auransa Announces Successful First Patient Dosed in Phase 1 Clinical Trial for Liver Cancer (EIN News) - "Auransa...announced dosing of the first patient in its Phase 1 clinical trial to evaluate AU-409 as a treatment for patients with advanced liver cancers or solid tumors affecting the liver. The patient was treated at the USC Norris Comprehensive Cancer Center where Anthony El-Khoueiry, MD is the principal investigator on the trial."

Trial status • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor