A Study of the Safety and Tolerability of BMS-986183 in Patients With Liver Cancer

Official Title

A Phase 1/2 Study of BMS-986183 in Subjects With Advanced Hepatocellular Carcinoma

Summary:

The purpose of this study is to evaluate the safety and tolerability of BMS-986183 in patients with liver cancer.

Trial Description

Primary Outcome:

• Incidence and Adverse Events (AEs) at its worst grade
• Incidence of Serious Adverse Events (SAEs) at its worst grade
• Incidence of AEs leading to discontinuations
• Incidence of AEs leading to death
• Frequency of laboratory test toxicity grade shifting from baseline

• Best overall response (BOR)
• Overall response rate (ORR)
• Duration of response (DOR)
• Progression free survival (PFS)
• Changes in Fridericia-corrected QT interval (ΔQTcF)
• Frequency of different subject immunogenicity status
• Cmax (maximum observed serum and/or plasma concentration)
• Tmax (time of maximum observed serum and/or plasma concentration)
• AUC(0-t) (area under the concentration-time curve from time 0 to time t)
• AUC(TAU) (area under the concentration-time curve in 1 dosing interval)
• Ctau (concentration at the end of a dosing interval)
• Ctrough (trough observed serum and/or plasma concentration, including predose concentrations and Ctau concentrations)
• CLT (total body clearance calculated as dose divided by AUC(TAU)
• Vss (apparent volume of distribution at steady-state)
• Vz (volume of distribution of terminal phase)
• AI_Cmax (accumulation index; ratio of Cmax at steady-state to Cmax after the first dose)
• AI_Ctau (accumulation index; ratio of Ctau at steady-state to Ctau after the first dose)

View this trial on ClinicalTrials.gov