TAK-676 as Single Agent (SA) and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumours

Titre officiel

An Open-label, Dose Escalation, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-676 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced or Metastatic Solid Tumours

Sommaire:

The purpose of this study is to determine the safety and tolerability of TAK-676 administered as an SA or in combination with pembrolizumab in participants with advanced or metastatic solid tumours.

Description de l'essai

Primary Outcome:

  • Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity
  • Number of Participants with Dose-Limiting Toxicities (DLTs)
  • Number of Participants Reporting One or More Treatment Emergent Serious Adverse Event (SAEs)
  • Number of Participants With one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations
Secondary Outcome:
  • Cmax: Maximum Observed Plasma Concentration for TAK-676
  • Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-676
  • AUCt: Area under the Concentration-time Curve From Time 0 to Time t for TAK-676
  • AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity for TAK-676
  • t1/2: Terminal Disposition Phase Half-life for TAK-676
  • CL: Total Clearance After Intravenous Administration for TAK-676
  • Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-676
  • CLR: Renal Clearance for TAK-676
  • Percentage of Dose Excreted in Urine During 24 Hours After Dosing
  • CLR/CL%: Renal Clearance as Percentage of Total Clearance for TAK-676
  • Overall Response Rate (ORR)
  • Disease Control Rate (DCR)
  • Duration of Response (DOR)
  • Time to Response (TTR)
  • Number of Participants with Upregulation of TAK-676-Induced Stimulator of Interferon Genes (STING)

Voir cet essai sur ClinicalTrials.gov

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