RecruitingPhase 2NCT05257590

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

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

Sponsor

TaiRx, Inc.

Enrollment

95 participants

Start Date

May 23, 2022

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma Advanced Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination treatment — CVM-1118 with the immunotherapy drug nivolumab — for people with advanced liver cancer (hepatocellular carcinoma) that cannot be removed by surgery and has stopped responding to previous treatments. **You may be eligible if...** - You are 18 years or older (20 or older if you are in Taiwan) - You have been diagnosed with liver cancer (hepatocellular carcinoma) - Your cancer is at an advanced stage and cannot be surgically removed - Your cancer has progressed after or you could not tolerate previous treatments such as sorafenib, lenvatinib, or atezolizumab plus bevacizumab - Your liver function is still adequate **You may NOT be eligible if...** - You have not previously tried standard treatments for advanced liver cancer - You have severe liver problems (Child-Pugh C) - You have uncontrolled infections or other serious health conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNivolumab 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.

DRUGCVM-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.