Status:
RECRUITING
CVM-1118 in Combination With Nivolumab for Unresectable Advanced Hepatocellular Carcinoma
Lead Sponsor:
TaiRx, Inc.
Conditions:
Hepatocellular Carcinoma
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 s...
Detailed Description
Nivolumab, a human IgG4 kappa monoclonal antibody acts as a checkpoint inhibitor, blocking the interaction between PD-1 and its ligands (PD-L1 and PD-L2 ) and therefore preventing the activation of T ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT05257590
Start Date
May 23 2022
End Date
March 31 2026
Last Update
December 17 2025
Active Locations (5)
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1
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
2
Keelung Chang Gung Memorial Hospital
Keelung, Taiwan
3
National Cheng Kung University Hospital
Tainan, Taiwan
4
National Taiwan University Hospital
Taipei, Taiwan, 100