A Phase 2, Open-Label Study of CVM-1118 in Combination With Nivolumab in Subjects With Unresectable Advanced Hepatocellular Carcinoma

CVM-008

CVM-1118 is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by TaiRx, Inc. CVM-1118 is a potent anti-cancer agent in numerous human cancer cell lines. The safety of administrating CVM-1118 on human has been evaluated from the phase 1 study. The objective of the phase 2 study is to further investigate the efficacy of CVM-1118 with nivolumab for subjects with unresectable advanced hepatoma.

2022-05-23

2025-09-30

2026-03-31

Recruiting

Early phase I

95

Inclusion Criteria: * Age 18+ (20+ for subjects in Taiwan) * Diagnosis of hepatocellular carcinoma * Pathologically or cytologically-confirmed or clinically diagnosed in accordance with American Association for the Study of Liver Diseases (AASLD) criteria (i.e., radiologic imaging with cross-sectional multiphasic contrast CT or MRI showing a ≥ 1 cm liver lesion) * Subjects with advanced-stage, unresectable hepatocellular carcinoma that is not appropriate for potentially curable therapy who have progressed from, been intolerant of prior systemic anti-cancer therapies (e.g., sorafenib, lenvatinib, atezolizumab in combination with bevacizumab). * Barcelona Clinic Liver Cancer (BCLC) stage B not appropriate for or with disease progression after local regional therapy, or BCLC stage C * Child-Pugh liver function class A * Measurable disease (per mRECIST) * ECOG performance status of 0 to 1 * Adequate laboratory parameters including: * AST and ALT ≤ 3.0 x ULN (≤ 5.0 x ULN if due to liver involvement) * Total serum bilirubin ≤ 2.0 x ULN (≤ 3.0 x ULN for subjects with documented Gilbert's syndrome) * ANC ≥1500/µL * Platelets ≥ 90,000/µL * HGB ≥ 9.0 g/dL * Serum creatinine clearance of ≥ 50 mL/min based on Cockcroft-Gault formula * Serum albumin ≥ 2.8 gm/dL * INR ≤ 2.3 * PT/aPTT ≤ 1.2 x ULN * QTcF ≤ 480 msec * Subjects are eligible to enroll if they have HBV-, or HCV-HCC, defined as follows: * Chronic HBV infection as evidenced by detectable HBV DNA or HBsAg. Subjects with chronic HBV infection must be on antiviral therapy and have HBV DNA \<500 IU/mL. If not on an antiviral therapy at screening, then subjects must be willing to start the antiviral therapy at the time of consent. * Active or resolved HCV infection as evidenced by detectable HCV RNA or antibody. Exclusion Criteria: * HCC with portal vein invasion at the main portal branch (Vp4) * Known history of esophageal varices or gastrointestinal bleeding within the past 3 months * Prior immunotherapy for hepatoma * ≤ 7 days from prior limited field palliative irradiation therapy and C1D1 * ≤ 28 days from prior irradiation therapy and C1D1 * ≤ 14 days (or 5 half-lives) from prior systemic anticancer therapy and C1D1 * ≤ 28 days from local regional therapy (e.g., trans-arterial embolization, radiofrequency ablation) and C1D1 * Presence of other active cancer(s) likely to require treatment in the next two (2) years or likely to impact the assessment of any study endpoints * Active bacterial or fungal infection(s) requiring systemic therapy within 7 days prior to C1D1 * Known CNS metastases * Known history of HIV infection * Females who are currently pregnant or breast-feeding * Known gastrointestinal disease that may significantly alter the absorption of oral medications * Psychiatric illness or social situation that would interfere with compliance with study requirements * History of clinically significant cardiovascular abnormalities

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 95, 'type': 'ESTIMATED'}}

2023-12-05