A PHASE IB, PROOF OF MECHANISM, OPEN-LABEL STUDY OF RO7070179, A HYPOXIA-INDUCIBLE FACTOR 1A (HIF1A) mRNA ANTAGONIST IN ADULT SUBJECTS WITH HEPATOCELLULAR CARCINOMA (HCC)

Protocol: 
AAAQ4550
Phase: 
I

A PHASE IB, PROOF OF MECHANISM, OPEN-LABEL STUDY OF RO7070179, A HYPOXIA-INDUCIBLE FACTOR 1A (HIF1A) mRNA ANTAGONIST IN ADULT SUBJECTS WITH HEPATOCELLULAR CARCINOMA (HCC)

The purpose of this study is to assess the safety, tolerability, and effectiveness of RO7070179 given to patients with Hepatocellular Carcinoma (HCC), a primary type of liver cancer, with normal to moderately impaired liver function. RO7070179 is given intravenously to study its effects in the treatment of liver cancer. RO7070179 is an investigational anti-cancer agent and acts by inhibiting the growth of the tumor. It is designed to lower the amount of a protein called hypoxia-indicible factor-1 alpha (HIF1A). HIF1A helps cancer cells survive when hypoxia occurs (low oxygen). RO7070179 lowers the amount of HIF1A by binding and destroying the message that tells the cancer cells to make HIF1A. However, it is not known if RO7070179 will lower the amount of HIF1A in HCC and if this will slow the growth of HCC. The study plans to find out whether RO7070179 affects the amount of HIF1A RNA present and whether HIF1A protein is reduced in the tumors of patients with HCC. The study will also find out if the drug is safe in patients with HCC and whether the tumor of patients with HCC are affected in an open-label study design.

Are you Eligible? (Inclusion Criteria)

1. Confirmed to have HCC based on representative features of radiological criteria as described by the American Association for the Study of Liver Disease (AASLD)
2. Patients who have failed at least one line of systemic therapy for advanced stage HCC or who are ineligible or unable to tolerate the standard of care treatment
3. Have measurable or evaluable disease. Measurable disease should be evaluated using The Response Evaluation Criteria in Solid Tumors (RECIST) Versio Patients with normal major organ functions as defined by hemoglobin (HgB) >= 8.5 g/dL, ANC>= 1000/?L, platelet >= 60,000/?L, AST/ALT <= 3 × upper limit of normal (ULN), total bilirubin <= 2 ×ULN, Cr <= 2 ×ULN
4. Willingness to undergo two tumor biopsies: before and after administration of RO7070179 on 1.1 and Response

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States