Spots Global Cancer Trial Database for Study on Safety and Efficacy of NMS-01940153E in Adult Patients With Unresectable Hepatocellular Carcinoma (HCC) Previously Treated With Systemic Therapy
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Trial Identification
Brief Title: Study on Safety and Efficacy of NMS-01940153E in Adult Patients With Unresectable Hepatocellular Carcinoma (HCC) Previously Treated With Systemic Therapy
Official Title: Phase I/II Study on Safety and Efficacy of NMS-01940153E in Adult Patients With Unresectable Hepatocellular Carcinoma (HCC) Previously Treated With Systemic Therapy
Study ID: NCT05630937
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California Irvine Health, Orange, California, United States
Siteman Cancer Center - Washington University Medical Campus, Saint Louis, Missouri, United States
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Azienda Sanitaria Locale Napoli 1 Centro - Ospedale del Mare, Naples, , Italy
Istituto Oncologico Veneto - IRCCS, Padova, , Italy
Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara, Pisa, , Italy
Istituto Clinico Humanitas, Rozzano, , Italy
Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, , Italy
Hospital Clínic de Barcelona, Barcelona, , Spain
Contact Details
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