Overview

CVM-1118 in Combination With Nivolumab for Unresectable Advanced Hepatocellular Carcinoma

Status:
Not yet recruiting
Trial end date:
2026-03-01
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
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