A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumours

Official Title

A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumours

Summary:

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab in participants with advanced solid tumours. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumours.

Trial Description

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 AEs leading to death
  • Incidence of clinically significant changes in clinical laboratory results: Hematology tests
  • Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests
  • Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Secondary Outcome:
  • Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax)
  • PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax)
  • PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU))
  • PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau)
  • PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax)
  • PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax)
  • PK parameters of BMS-986340 administered in combination with nivolumab: Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
  • PK parameters of BMS-986340 administered in combination with nivolumab: Observed concentration at the end of the dosing interval (Ctau)
  • Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy
  • Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab
  • Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 by investigator
  • Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 by investigator
  • Duration of response (DOR) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 by investigator
  • Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 by investigator

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society