First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumours

Titre officiel

Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumours

Sommaire:

The purpose of this study is to determine whether BMS-986218 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumours.

Description de l'essai

Primary Outcome:

  • Incidence of Adverse Events (AEs)
  • Incidence of Serious Adverse Events (SAEs)
  • Incidence of AEs meeting protocol- defined dose-limiting toxicity (DLT) criteria
  • Incidence of AEs leading to discontinuation
  • Incidence of death
  • Objective Response Rate (ORR)
  • Median Duration of Response (mDOR)
  • Progression Free Survival Rate (PFSR) by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
Secondary Outcome:
  • ORR
  • mDOR
  • PFSR by RECIST v1.1
  • Incidence of anti-drug antibody (ADA)
  • Maximum observed plasma concentration (Cmax)
  • Time of maximum observed plasma concentration (Tmax)
  • Trough observed serum concentration (Ctrough)

Voir cet essai sur ClinicalTrials.gov

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