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

Official Title

An Open-Label, Multicentre, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumour Activity of RO7296682 in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumours

Summary:

This study will evaluate the safety, tolerability and preliminary anti-tumour activity of RO7296682 in combination with Atezolizumab in participants with advanced solid tumours.

Trial Description

Primary Outcome:

  • Percentage of Participants with Adverse Events (AEs)
  • Percentage of Participants with Dose-Limiting Toxicities (DLTs)
  • Objective Response Rate (ORR) (Part II and III only)
Secondary Outcome:
  • Objective Response Rate (ORR) (Part I only)
  • Disease Control Rate (DCR)
  • Duration of Response (DoR)
  • Progression-Free Survival (PFS)
  • Overall Survival (OS)
  • Area under the Curve (AUC) of RO7296682
  • Minimum Concentration (Cmin) of RO7296682
  • Maximum Concentration (Cmax) of RO7296682
  • Time of maximum concentration (Tmax) of RO7296682
  • Volume of distribution at steady-state conditions (Vss) of RO7296682
  • Half-life (t~1/2) of RO7296682
  • 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

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