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

Official Title

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.

Summary:

This study will evaluate the safety and tolerability of RO7296682 in participants with advanced solid tumours.

Trial Description

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).

View this trial on ClinicalTrials.gov