A Study of RO7009789 in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Solid Tumours

Official Title

An Open-Label, Multicentre, Dose-Escalation Phase IB Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Therapeutic Activity of RO7009789 (CD40 Agonist) in Combination With Atezolizumab (Anti PD-L1) in Patients With Locally Advanced and/or Metastatic Solid Tumours

Summary:

This is an open-label, multicentre study designed to assess the safety, pharmacokinetics, pharmacodynamics and activity of RO7009789 administered in combination with atezolizumab (ATZ) in participants with metastatic or locally advanced solid tumours. The study will be conducted in two Parts (I and II), with Part I divided into Parts IA and IB. All participants will be followed up for survival until death or loss of follow-up after the last visit or withdrawal of consent.

Trial Description

Primary Outcome:

  • Percentage of Participants with Adverse Events and Serious Adverse Events
  • Part IB: Percentage of Participants With Dose-Limiting Toxicities (DLTs)
  • Part IB: Maximum Tolerated Dose (MTD) of RO7009789
  • Part IB: Recommended Part II Dose of RO7009789
  • Part II: Recommended Dose of RO7009789 in Combination with Atezolizumab
Secondary Outcome:
  • Part IA: Area Under the Concentration Time Curve (AUC) of RO7009789
  • Part IA: Maximum Serum Concentration (Cmax) of RO7009789
  • Part IA: Time to Cmax (Tmax) of RO7009789
  • Part IA: Minimum Serum Concentration Under Steady-State (Cmin) of RO7009789
  • Part IA: Apparent Clearance (CL/F) of RO7009789
  • Part IA: Half-Life (t1/2) of RO7009789
  • Part IA: Cmax of Atezolizumab
  • Part IA: Cmin of Atezolizumab
  • Part IB: AUC of SC RO7009789
  • Part IB: Cmax of SC RO7009789
  • Part IB: Tmax of SC RO7009789
  • Part IB: Cmin of SC RO7009789
  • Part IB: CL/F of SC RO7009789
  • Part IB: Apparent Volume of Distribution (V/F) of SC RO7009789
  • Part IB: t1/2 of SC RO7009789
  • Part IB: Cmax of Atezolizumab
  • Part IB: Cmin of Atezolizumab
  • Part II: AUC of RO7009789
  • Part II: Cmax of RO7009789
  • Part II: Tmax of RO7009789
  • Part II: Cmin of RO7009789
  • Part II: CL/F of RO7009789
  • Part II: V/F of RO7009789
  • Part II: t1/2 of RO7009789
  • Part II: Cmax of Atezolizumab
  • Part II: Cmin of Atezolizumab
  • Part II: Percentage of Participants With Best Overall Response, as Determined by Investigator Using Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1
  • Part II: Percentage of Participants With Best Overall Response, as Determined by Investigator Using Unidimensional Immune-Related Response Criteria (irRC)
  • Part II: Percentage of Participants With Disease Control, as Determined by Investigator Using RECIST Version 1.1
  • Part II: Percentage of Participants With Disease Control, as Determined by Investigator Using Unidimensional irRC
  • Part II: Duration of Objective Response, as Determined by Investigator Using RECIST Version 1.1
  • Part II: Duration of Objective Response, as Determined by Investigator Using Unidimensional irRC
  • Part II: Progression-Free Survival (PFS), as Determined by Investigator Using RECIST Version 1.1
  • Part II: Overall Survival
  • Part IA, IB, and II: Percentage of Participants With Auto-antibodies
  • Part IA, IB, and II: Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to RO7009789
  • Part IA, IB, and II: Percentage of Participants With ATA to ATZ
  • Part IA: Levels of Circulating Rabbit Polyclonal Antibody (Ki67) T Cells Assessed by Immunophenotyping by Flow Cytometry
  • Part IB: Levels of Circulating Ki67 T Cells Assessed by Immunophenotyping by Flow Cytometry
  • Part II: Levels of Circulating Ki67 T Cells Assessed by Immunophenotyping by Flow Cytometry
  • Part IA: Levels of Cluster of Differentiation 8 (CD8+) Cells Tumour-Infiltration Assessed by Immunophenotyping by Flow Cytometry
  • Part IB: Levels of CD8+ Cells Tumour-Infiltration Assessed by Immunophenotyping by Flow Cytometry
  • Part IA: Levels of Programmed Death Ligand 1 (PD-L1) Expression on Both Tumour and Immune-Infiltrating Cells Assessed by Immunophenotyping by Flow Cytometry
  • Part IB: Levels of PD-L1 Expression on Both Tumour and Immune-Infiltrating Cells Assessed by Immunophenotyping by Flow Cytometry
  • Part II: Levels of PD-L1 Expression on Both Tumour and Immune-Infiltrating Cells Assessed by Immunophenotyping by Flow Cytometry
  • Part IA: V/F of RO7009789
  • Part II: PFS, as Determined by Investigator Using Unidimensional irRC
  • Part II: Levels of CD8+ Cells Tumour-Infiltration Assessed by Immunophenotyping by Flow Cytometry
  • Part IB: AUC of IV RO7009789
  • Part IB: Cmax of IV RO7009789
  • Part IB: Cmin of IV RO7009789
  • Part IB: Total Clearance (CL) of IV RO7009789
  • Part IB: Volume of Distribution (Vss) of IV RO7009789
  • Part IB: t1/2 of IV RO7009789

View this trial on ClinicalTrials.gov

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Resources

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