OncoMatch/Clinical Trials/NCT05791448
AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease
Is NCT05791448 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies RNA Transcription Modulator AU-409 for advanced cholangiocarcinoma.
Treatment: RNA Transcription Modulator AU-409 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Hepatocellular Carcinoma
Tumor Agnostic
Disease stage
Required: Stage STAGE III, STAGE IV (AJCC v8)
advanced solid tumor; Stage III Hepatocellular Carcinoma AJCC v8; Stage IV Hepatocellular Carcinoma AJCC v8
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anticancer therapy
Exception: palliative radiation therapy completed >= 14 days prior to study entry
Treatment with other anticancer therapies (including surgery, radiation therapy, chemotherapy, anti-angiogenic therapy, targeted therapy, or radiofrequency ablation therapy, etc.) or investigational therapy within 28 days prior to study entry (except for palliative radiation therapy that should be completed >= 14 days prior to study entry)
Lab requirements
Blood counts
ANC >= 1500/mm^3 (>= 1000/mm^3 for HCC with splenic sequestration); Platelet count >= 100,000/mm^3 (>= 70,000 for HCC with splenic sequestration); Hemoglobin >= 8 g/dL (prior transfusion allowed if completed 2 weeks prior to screening and hemoglobin remains >= 8 g/dL)
Kidney function
Calculated clearance >= 60 mL/min/1.73 m^2 (actual body weight or lean body weight for BMI > 30 kg/m^2)
Liver function
Total bilirubin <= 1.5 X ULN (subjects with known Gilbert's hepatic function disease can have bilirubin of up to 2 X ULN); AST/ALT <= 3 X ULN; or AST/ALT <= 5 X ULN if patient has liver tumors; Prothrombin time (PT)/INR <= 1.8 times ULN (unless patient is on anticoagulation)
Cardiac function
QTc interval <= 470 msec (Fredericia's equation) on 2 out of 3 ECGs
Absolute neutrophil count (ANC) >= 1500/mm^3; Platelet count >= 100,000/mm^3; Hemoglobin >= 8 g/dL (prior transfusion is allowed if completed 2 weeks prior to screening and hemoglobin remains >= 8 g/dL); For patients with HCC with splenic sequestration: ANC >= 1000/mm^3; For patients with HCC with splenic sequestration: Platelets >= 70,000; Calculated clearance >= 60 mL/min/1.73 m^2. Actual body weight should be used for calculating creatinine clearance (e.g., using the Cockroft-Gault formula). For subjects with a Body Mass Index (BMI) > 30 kg/m^2, lean body weight should be used instead; Total bilirubin <= 1.5 X upper limit of normal (ULN) (subjects with known Gilbert's hepatic function disease can have bilirubin of up to 2 X ULN); Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <= 3 X ULN; or AST/ALT <= 5 X ULN if patient has liver tumors; Prothrombin time (PT)/international normalized ratio (INR) <= 1.8 times upper limit of normal (unless patient is on anticoagulation); Patients who have corrected QT (QTc) interval to > 470 msec (Fredericia's equation) on 2 out of 3 electrocardiogram (ECG)'s (if first ECG has QTc < 470, no need to repeat, if first ECG has QTc > 470 repeat twice for a total of 3 ECG's)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Los Angeles County-USC Medical Center · Los Angeles, California
- USC / Norris Comprehensive Cancer Center · Los Angeles, California
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