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NCT05791448 · ClinicalTrials.gov record · last posted 2026-08-17

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

StatusSuspended
PhasePhase 1
Started2023-03-29
View on ClinicalTrials.gov ↗
Why the trial stopped
Pending protocol amendment
from the ClinicalTrials.gov record
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.

Protocol amendment history 4 changes detected by DataLookout

2026-08-18
Recruitment suspended
2026-08-18
Recruitment suspended: Pending protocol amendment
2026-06-02
Primary completion pushed: 2026-03-29 → 2027-03-29
2026-06-02
Completion pushed: 2027-03-29 → 2028-03-29
Trial Details
NCT Number NCT05791448
Lead Sponsor University of Southern California
Collaborators: National Cancer Institute (NCI), Auransa, Inc.
Conditions Advanced Cholangiocarcinoma, Advanced Hepatocellular Carcinoma, Advanced Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Liver, Refractory Malignant Solid Neoplasm, Stage III Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8
Enrollment 36 participants
Start Date 2023-03-29
Primary Completion 2027-03-29 (estimated)
Study Completion 2028-03-29 (estimated)
Updated on ClinicalTrials.gov 2026-08-17