A Study Evaluating Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281 as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)

Official Title

An Open-Label, Multicentre, Dose-Escalation, Phase Ia/Ib Study to Evaluate Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281, an Immunocytokine Consisting of Interleukin 2 Variant (IL-2v) Targeting Fibroblast Activation Protein-α (FAP), as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)

Summary:

This first-in-human, open-label, multicentre, Phase Ia/Ib, adaptive, multiple ascending-dose study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumour activity of RO6874281 as a single agent (Part A) or in combination with trastuzumab or cetuximab (Part B or C).

Trial Description

Primary Outcome:

• Percentage of Participants With Dose-Limiting Toxicities (DLTs)
• Maximum Tolerated Dose (MTD) of RO6874281
• Optimal Biological Dose (OBD) of RO6874281
• Recommended Dose for Further Development of RO6874281
• Systemic Clearance (CL) of RO6874281
• Volume of Distribution at Steady State (Vss) of RO6874281
• Area Under the Concentration-Time Curve (AUC) of RO6874281
• Maximum Observed Serum Concentration (Cmax) of RO6874281

• Number of T Cells in the Peripheral Blood
• Number of Natural Killer (NK) Cells in the Peripheral Blood
• Density of Cluster of Differentiation (CD)8+ Cells in Tumour Samples
• Density of CD3-/Perforin+ Cells in Tumour Samples
• Density of CD20 Cells in Tumour Samples
• Percentage of Participants With Overall Response According to Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1)
• Percentage of Participants With Disease Control According to RECIST v1.1
• Progression-Free Survival (PFS) According to RECIST v1.1
• Percentage of Participants With Overall Response According to Modified RECIST
• Percentage of Participants With Disease Control According to Modified RECIST
• PFS According to Modified RECIST
• Percentage of Participants With Overall Response According to iRECIST
• Percentage of Participants With Disease Control According to iRECIST
• PFS According to iRECIST

View this trial on ClinicalTrials.gov