An Investigational Immuno-therapy Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Solid Cancers That Are Advanced or Have Spread

Titre officiel

Phase 1/2a First-In-Human Study of BMS-986207 Monoclonal Antibody Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumours

Sommaire:

Une étude visant à évaluer l’innocuité et la tolérabilité de l’anticorps monoclonal BMS-986207 en monothérapie ou en association avec le nivolumab dans le traitement de cancers avancés (tumeur solide).

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 deaths
  • 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 tests
  • Objective response rate (ORR)
  • Median duration of response (mDOR)
  • Progression-free survival rate (PFSR) at 24 weeks by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 by Investigator
Secondary Outcome:
  • Objective response rate (ORR)
  • Median duration of response (mDOR)
  • Progression-free survival rate (PFSR) at 24 weeks by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
  • Maximum observed serum concentration (Cmax)
  • Time of maximum observed serum concentration (Tmax)
  • Area under the serum concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)
  • Area under the concentration-time curve in one dosing interval AUC(TAU)
  • Observed concentration at the end of a dosing interval (Ctau)
  • Total body clearance (CLT)
  • Average concentration over a dosing interval (Css-avg)
  • Accumulation Index (AI)
  • Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALFeff)
  • Trough observed serum concentrations (Ctrough)
  • Incidence of anti-drug antibody (ADA)

Voir cet essai sur ClinicalTrials.gov

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