A Study to Evaluate the Safety and Tolerability of RO7296682 in Participants With Advanced Solid Tumours.

Titre officiel

An Open-label, Multicentre Phase 1 Study to Evaluate Safety, Tolerability, PK (Pharmacokinetics)/PD (Pharmacodynamics) of RO7296682, a T-regulatory Cell Depleting Antibody in Participants With Advanced and/or Metastatic Solid Tumours.

Sommaire:

Cette étude évaluera l’innocuité et la tolérabilité du RO7296682 chez des participants atteints de tumeurs solides à un stade avancé.

Description de l'essai

Primary Outcome:

  • Percentage of Participants with Adverse Events
  • Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Secondary Outcome:
  • Objective Response Rate (ORR)
  • Disease Control Rate (DCR)
  • Duration of Response (DOR)
  • Progression-Free Survival (PFS)
  • Area under the curve (AUC) of RO7296682
  • Minimum Concentration (Cmin) of RO7296682
  • Maximum Concentration (Cmax) of RO7296682
  • Clearance (CL) of RO7296682
  • Volume of distribution at steady-state conditions (Vss) of RO7296682
  • Half-life (t~1/2) of RO7296682
  • Time of maximum concentration (Tmax) of RO7296682
  • Incidence and titer of Anti-Drug Antibodies (ADA) during the study relative to the prevalence of ADA at baseline
  • Treatment-induced changes in Treg levels in blood and/or tumour as compared to baseline
  • Treatment-induced changes in Treg/Teff (T-regulatory cell; T-effector cell) ratio in blood and/or tumour as compared to baseline
A Phase 1, open-label, dose-escalation study designed to evaluate the safety and tolerability of RO7296682 in participants with advanced and/or metastatic solid tumours. RO7296682 will be administered by intravenous (IV) infusion every 3 weeks. This entry-into-human study is divided into a dose-escalation stage (Part A) and a dose expansion stage (Part B).

Voir cet essai sur ClinicalTrials.gov

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