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

NCT05257590 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Nivolumab Injection [Opdivo]

Nivolumab will be administered at 240 mg, IV, Q2 weeks with an option for 480 mg, IV, Q4 weeks starting with Cycle 3 if judged to be reasonable by the investigator based on the safety and tolerability.

DRUG

CVM-1118

CVM-1118 will be administered 200 mg, PO, BID with an option to increase the starting dose to 300 mg, PO, BID for the subsequent subjects following assessment of safety data from the initial 10 subjects.

Sponsors & Collaborators

  • TaiRx, Inc.

    lead INDUSTRY

Principal Investigators

  • Pei-Jer Chen, MD/PhD · National Taiwan University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-23
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05257590 on ClinicalTrials.gov