CVM-1118 in Combination With Nivolumab for Unresectable Advanced

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 cells from attacking the cancer. Nivolumab is currently approved for several cancer types. To meet the medical need, TaiRx, Inc. develops a new small molecule drug, CVM-1118 can promote apoptosis and delay proliferation. Moreover, CVM-1118 targets the formation of vasculogenic mimicry (VM). VM has been associated with tumor metastasis and poor clinical outcomes. VM is reported to be particularly active in tumor under hypoxia state when patients are treated with the potent vascular endothelial growth factor (VEGF) inhibitor like sorafenib or bevacizumab. Hence, the ability of inhibiting the VM network makes CVM-1118 a potential good combination drug with Nivolumab in advanced diseases such as hepatoma where Nivolumab alone has shown activity. The safety profile of CVM-1118 dosing has been established in the phase 1 study. The analysis of metabolism pathways further showed that the potential drug-drug interactions of CVM-1118 and Nivolumab are very low. Based on the mechanism of actions and the safety analysis of nivolumab and CVM-1118, the design of phase 2 trial with the combination therapy might have great potential for the patients with unresectable advanced HCC. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05257590
Study type	Interventional
Source	TaiRx, Inc.
Contact	Yen-Ling Chen, PhD
Phone	886-2-2653-5007
Email	yenlingchen@trx.com.tw
Status	Recruiting
Phase	Phase 2
Start date	May 23, 2022
Completion date	March 31, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms