A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumours

Official Title

A Phase 1b/2 Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumours

Summary:

This study will evaluate the safety profile, tolerability, PK, PD, and preliminary efficacy of BMS-813160 alone or in combination with either chemotherapy or nivolumab in participants with metastatic colorectal and pancreatic cancers.

Trial Description

Primary Outcome:

• Adverse events (AEs)
• Serious adverse events (SAEs)
• AEs meeting protocol-defined dose limiting toxicity criteria
• AEs leading to discontinuation
• Death
• Incidence of laboratory abnormalities
• Electrocardiogram (ECG)
• Summary measures of vital signs
• Overall response rate (ORR)
• Median duration of response (DOR)
• Progression free survival (PFS) rate
• Decrease in regulatory T cells (Treg) & tumour-associated macrophages (TAM) in tumour samples

• Maximum observed plasma concentration (Cmax)
• Time of maximum observed plasma concentration (Tmax)
• Trough observed plasma concentration (Ctrough)
• Observed plasma concentration at 24 hours post dose (C24)
• Area under the concentration-time curve from time 0 to 8 hours postdose [AUC(0-8)]
• Area under the concentration-time curve from time 0 to 24 hours post dose [AUC(0-24)]
• Apparent total body clearance (CLT/F)
• Accumulation index, calculated based on ratio of AUC(0-24) and Cmax at steady state to after the first dose (AI)
• Renal clearance (CLR)
• Percent urinary recovery over 24 hours corrected for molecular weight (%UR)
• Ratio of metabolite Cmax to parent Cmax, corrected for molecular (MR_Cmax)
• Ratio of metabolite AUC(0-24) to parent AUC(0-24), corrected for molecular weight [MR_AUC(0-24)]
• Frequency of positive anti-drug antibody (ADA) to nivolumab during combination therapy
• Decrease in regulatory T cells (Treg) & tumour-associated macrophages (TAM) in tumour samples
• Overall response rate (ORR)
• Median duration of response (DOR)
• Progression free survival (PFS) rate

View this trial on ClinicalTrials.gov