RecruitingPhase 1NCT05791448

AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease

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

Sponsor

University of Southern California

Enrollment

36 participants

Start Date

Mar 29, 2023

Study Type

INTERVENTIONAL

Conditions

Stage III Hepatocellular Carcinoma AJCC v8 Stage IV Hepatocellular Carcinoma AJCC v8 Refractory Malignant Solid Neoplasm Advanced Malignant Solid Neoplasm Advanced Cholangiocarcinoma Advanced Hepatocellular Carcinoma Metastatic Malignant Neoplasm in the Liver

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called AU409 for people with advanced liver cancers (including hepatocellular carcinoma and cholangiocarcinoma) or other solid tumors where the cancer has significantly spread to the liver. AU409 is designed to be delivered directly to the liver via the blood supply in a targeted way. **You may be eligible if...** - You are 18 or older - You have a confirmed advanced solid tumor that has not responded to standard treatments - Your cancer is primarily in the liver, or the liver is the dominant site of cancer spread - You are in good enough health (ECOG 0–1) - You have recovered from any serious side effects of previous treatments **You may NOT be eligible if...** - Your cancer has spread extensively outside the liver (more than two organ systems) - You have not recovered from prior treatment side effects - You have active infections or significant organ dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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