A Study to Evaluate Safety and Anti-Tumour Activity of RO7284755 Alone or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumours

Official Title

An Open-Label, Multicentre, Randomized, Dose-Escalation and Extension, Phase IA/IB Study to Evaluate Safety and Anti-Tumour Activity of RO7284755, A PD-1 Targeted IL-2 Variant (IL-2V) Immunocytokine, Alone or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumours

Summary:

This is an entry-into-human study and will assess the effects of RO7284755 as a single agent and in combination with atezolizumab in adult participants with solid tumours considered responsive to checkpoint inhibition blockade. The maximum duration in the study for each participant will be up to 28 months.

Trial Description

Primary Outcome:

• Percentage of Participants with Adverse Events in Part 1 and Part 2
• Percentage of Participants with Dose-Limiting Toxicities
• Investigator Assessed Objective Response Rate according to Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in Part 3
• Recommended Dose for Extension (RDE) of RO7284755 in Parts 1 and 2

Secondary Outcome:

• Investigator Assessed Objective Response Rate according to Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in Parts 1 and 2
• Percentage of Participants with Adverse Events in Part 3
• Disease Control Rate in Part 3
• Duration of Response in Part 3
• Progression-free survival (PFS) in Part 3
• Change from Baseline in Antidrug Antibody (ADA) to RO7284755
• Percentage of Partcipants with ADAs to RO7284755
• Area Under the Curve (AUC) for RO7284755
• Minimum Concentration (Cmin) for RO7284755
• Maximum Concentration (Cmax) for RO7284755
• Clearance (CL) for RO7284755
• Volume of Distribution at Steady-State Conditions (Vss) for RO7284755
• Percentage of Immune and Tumour Cells with Positive Programmed Cell Death-1 (PD-1) and Programmed Cell Death-Ligand 1 (PD-L1) Expression in the Tumour Microenvironment (TME)
• Percentage of Immune Cells with CD8+ PD1+ and CD8+ PD1+ TCF7+ Expression
• Blood Tumour Mutational Burden
• Change from Baseline in Percentage of Immune Cell Subsets
• Change from Baseline in Percentage of Immune Markers

The study consists of three parts: dose-escalation of RO7284755 as a single agent (Part 1), dose-escalation of RO7284755 in combination with atezolizumab (Part 2), and extension of RO7284755 as a single agent and/or in combination with atezolizumab (Part 3).

View this trial on ClinicalTrials.gov