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 a Monoclonal Antibody 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
  • Incidence of clinically significant changes in clinical laboratory results: Hematology tests
  • Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
  • Incidence of clinically significant changes in clinical laboratory results: Urinalysis
  • 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 of BMS-986218 alone or in combination with Nivolumab
  • mDOR of BMS-986218 alone or in combination with Nivolumab
  • PFS of BMS-986218 alone or in combination with Nivolumab
  • Incidence of anti-drug antibody (ADA) to BMS-986218
  • Maximum observed serum concentration (Cmax)
  • Time of maximum observed concentration (Tmax)
  • Area under the concentration-time curve from time zero to the time of the
  • Area under the concentration-time curve in 1 dosing interval [AUC(TAU)]
  • Trough observed serum concentration (Ctrough)
  • Total body clearance (CLT)
  • Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg)
  • Ratio of an exposure measure at steady state to that after the first dose [exposure measure includes AUC[TAU] and Cmax (AI)]
  • Terminal serum half-life if data permit (T-HALF)
  • Observed concentration at the end of a dosing interval (Ctau)

Voir cet essai sur ClinicalTrials.gov

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