A Study of RO7198457 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumours

Official Title

A Phase 1a/1b Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Tumours

Summary:

This is a Phase 1a/1b, open-label, multicentre, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of RO7198457 as a single agent and in combination with atezolizumab (MPDL3280A, an engineered anti-programmed death-ligand 1 [anti-PD-L1] antibody).

Trial Description

Primary Outcome:

  • Percentage of Participants with Dose-Limiting Toxicities (DLTs)
  • MTD/Recommended Phase 2 Dose (RP2D) of RO7198457
  • Percentage of Participants with Adverse Events (AEs)
  • Percentage of Participants with Immune-Mediated Adverse Events (imAEs)
  • Percentage of Participants by Number of Treatment Cycles Received
  • Dose Intensity of RO7198457
  • Change from baseline in targeted vital signs
  • Change from baseline in targeted clinical laboratory test results
  • Change from baseline in ECGs
Secondary Outcome:
  • Percentage of Participants with Objective Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria for Solid Tumours Version 1.1 (RECIST v1.1)
  • Duration of Response (DoR) According to RECIST v1.1
  • Percentage of Participants with Objective Response of CR or PR According to Immune-Modified RECIST
  • DoR According to Immune-Modified RECIST
  • Progression-Free Survival (PFS) According to RECIST v1.1
  • Overall Survival (OS)
  • Percentage of Participants with Anti-Drug Antibodies (ADAs) to Atezolizumab

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