Overview
CVM-1118 in Combination With Nivolumab for Unresectable Advanced Hepatocellular Carcinoma
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2026-03-01
2026-03-01
Target enrollment:
0
0
Participant gender:
All
All
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 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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
TaiRx, Inc.Treatments:
Nivolumab
Criteria
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