A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics and Immunoregulatory Activity of Urelumab (BMS-663513) in Subjects With Advanced and/or Metastatic Malignant Tumors

简要总结

主要结局

次要结局

• T-HALF (Elimination half life) of urelumab when administered alone(Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up)
• CLT (Total body clearance) of urelumab when administered alone(Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up)
• AUC(TAU) of urelumab and nivolumab when co-administered(Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up)
• AUC(INF) of urelumab and nivolumab when co-administered(Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up)
• Safety of urelumab-nivolumab combination therapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors(From day 1 of treatment up to 100 days of follow-up)
• AUC(0-T) [Area under the concentration-time curve from time zero to the last quantifiable concentration] of urelumab when administered alone(Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up)
• AUC(TAU) [Area under the concentration-time curve in one dosing interval] of urelumab when administered alone(Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up)
• Cmax of urelumab when co-administered(Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up)
• AUC(0-T) of urelumab and nivolumab when co-administered(Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up)
• Vss of urelumab when co-administered(Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up)
• Tmax (Time of maximum observed serum concentration) of urelumab when administered alone(Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up)
• Tolerability of urelumab-nivolumab combination therapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors(From day 1 of treatment up to 100 days of follow-up)
• Cmax (Maximum observed serum concentration) of urelumab when administered alone(Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up)
• Ctrough (Trough observed serum concentration) of urelumab when administered alone(Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up)
• AUC(INF) [Area under the concentration-time curve from time zero to infinity and the extrapolated area] of urelumab when administered alone(Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up)
• Vss (Volume of distribution at steady state) of urelumab when administered alone(Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up)
• AI (Accumulation Index: ratio of AUC(TAU) and Cmax in cycle at steady state to those after the first cycle) of urelumab when administered alone(Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up)
• BOR of urelumab and nivolumab combination therapy(Every 6-8 weeks during the treatment period)
• Coeff of urelumab when co-administered(Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up)
• Ctrough of urelumab and nivolumab when co-administered(Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up)
• Tmax of urelumab and nivolumab when co-administered(Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up)
• T-HALF of urelumab when co-administered(Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up)
• CLT of urelumab when co-administered(Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up)
• Anti-drug Antibody (ADA) status of the subject in response to Urelumab when administered alone(Cycle 1, 2, 4, 8, 12, 16, up to 60 days of follow up)
• ADA status of the subject in response to Urelumab and Nivolumab when co-administered(Cycle 1, 2, 4, 5, 9, up to 100 days of follow up)
• Best overall response (BOR) of urelumab monotherapy(Every 6-8 weeks during the treatment period)