Actively Recruiting
AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease
Led by University of Southern California · Updated on 2026-02-02
36
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
Sponsors
U
University of Southern California
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histopathologically or cytologically confirmed advanced solid tumor refractory to standard therapies or without standard options
- During dose-escalation: primary liver malignancy or solid tumor with liver dominant disease with no more than two extrahepatic disease sites
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Recovery from previous treatment toxicities to grade 1 or lower, except alopecia; sensory neuropathy up to grade 2 allowed
- Previous therapies completed at least 4 weeks or five half-lives prior to AU409 start; palliative radiation completed at least 14 days prior
- Estimated life expectancy of at least 3 months
- Agreement to use adequate contraception during and after study participation as specified
- Agreement to undergo liver biopsy (subset of patients) and provide blood samples for pharmacokinetics
- Adequate blood counts and organ function as specified (ANC ≥1500/mm³, platelets ≥100,000/mm³, hemoglobin ≥8 g/dL, bilirubin ≤1.5x ULN, AST/ALT ≤3x ULN or ≤5x ULN with liver tumors, PT/INR ≤1.8 unless on anticoagulation)
- For hepatocellular carcinoma (HCC) with splenic sequestration: ANC ≥1000/mm³, platelets ≥70,000
- Calculated clearance ≥60 mL/min/1.73 m² using actual or lean body weight depending on BMI
You will not qualify if you...
- Hypersensitivity to pentamidine or any AU409 ingredients
- Other anticancer or investigational treatments within 28 days prior to entry (except palliative radiation >14 days prior)
- HCC patients with Child Pugh score ≥ B7
- Untreated or symptomatic central nervous system metastases; treated brain metastases allowed if completed ≥30 days prior and asymptomatic
- History within 6 months of serious cardiac or cerebrovascular events or severe heart failure
- QTc interval >470 msec on ECG
- Therapeutic anticoagulation with warfarin; low molecular weight heparins or Factor Xa inhibitors allowed
- History of gastrointestinal surgery or malabsorptive conditions affecting drug absorption
- Active hepatitis B infection unless on antiviral therapy with low viral load; chronic hepatitis C allowed
- Active infections requiring treatment except hepatitis B or C
- Immune compromise due to other conditions or treatments
- Other medical or mental conditions interfering with consent, participation, or result interpretation
- Pregnancy or nursing
- Use of strong cytochrome P450 inducers or inhibitors unless discontinued or replaced prior to study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Los Angeles County-USC Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
Research Team
X
Xiomara Menendez, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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