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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT05791448
Phase
PHASE1
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • RNA Transcription Modulator AU-409 — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Mar 29, 2023
Status verified
May 2026
Primary completion
Mar 29, 2027
Completion
Mar 29, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (AU409)
    Patients receive AU409 PO on study. Patients also undergo CT or MRI and collection of blood samples throughout the trial.

Primary Outcome Measure

Maximum Tolerated Dose [ Time Frame: Up to 28 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Los Angeles County-USC Medical CenterLos AngelesCalifornia90033
Xiomara Menendez, RN
[email protected]
323-865-0212
Anthony B. El-Khoueiry, MD (PRINCIPAL_INVESTIGATOR)
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Xiomara Menendez, RN
[email protected]
323-865-0212
Anthony B. El-Khoueiry, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Los Angeles County-USC Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CA

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