NCT05630937

Study on Safety and Efficacy of NMS-01940153E in Adult Patients With Unresectable Hepatocellular Carcinoma (HCC) Previously Treated With Systemic Therapy

Phase I/II Study on Safety and Efficacy of NMS-01940153E in Adult Patients With Unresectable Hepatocellular Carcinoma (HCC) Previously Treated With Systemic Therapy

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Nerviano Medical Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I/II, open-label, non-randomized, multicenter study to explore safety, tolerability and antitumor activity of NMS-01940153E as single agent in adult patients with unresectable hepatocellular carcinoma (HCC) previously treated with systemic therapy. The Phase I portion is designed as a dose-escalation study in sequential cohorts of patients aimed to obtain the maximum tolerated dose (MTD) that is defined based on the dose limiting toxicities (DLTs) observed in the first cycle of treatment. The Phase II portion is designed as a two-stage study with an interim analysis for futility and stopping criteria for unacceptable toxicity to assess the antitumor activity of NMS-01940153E in adult patients with unresectable HCC previously treated with systemic therapy measured as objective response rate.

Conditions

• Unresectable Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	NMS-01940153E	Route of administration: intravenous (IV) solution

Timeline

• Start date: 2020-11-13
• Primary completion: 2024-01-31
• Completion: 2024-08-06
• First posted: 2022-11-30
• Last updated: 2025-06-19
• Results posted: 2025-05-07

Locations

9 sites across 3 countries: United States, Italy, Spain

Regulatory

• FDA-regulated drug study