A Study of RO7009789 in Combination With MPDL3280A in Patients With Locally Advanced and 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 MPDL3280A (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 MPDL3280A in patients with metastatic or locally advanced solid tumours. The study will be conducted in three parts (I, II, and III), with part I divided into parts IA and IB and into subcutaneous (s.c.) and intravenous (i.v.) treatment groups. All patients 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:

  • Safety (composite outcome measure): Incidence and severity of adverse events and infusion-related reactions, incidence of autoantibodies, incidence of ADAs; changes in vital signs, physical findings, ECG findings, and clinical laboratory results
  • Incidence and severity of dose-limiting toxicities (DLTs)
Secondary Outcome:
  • Pharmacokinetic profile and parameters derived from the concentration-time curve following i.v. infusion of RO7009789 [AUC, Cmax, Cmin, CL, volume of distribution at steady state, half-life] (composite outcome measure)
  • Pharmacokinetic profile and parameters derived from the concentration-time curve following s.c. administration of RO7009789 [AUC, Cmax, time to Cmax (Tmax), Cmin, apparent clearance CL/F, volume of distribution (V/F), t1/2] (composite outcome measure)
  • Pharmacodynamics: levels of circulating Ki67+ T-cell levels
  • Pharmacodynamics: change in 18F-fluorothymidine (FLT) uptake by spleen
  • Pharmacokinetic profile and and parameters derived from the concentration-time curve following i.v. or s.c. administration of RO7009789 [AUC, Cmax, Cmin, volume of distribution at steady state, half-life] (composite outcome measure)
  • Pharmacokinetic profile and parameters derived from the concentration-time curve following IV infusion of MPDL3280A [Cmax, Cmin] (composite outcome measure)
  • Pharmacodynamics: change in CD8+ cells tumour-infiltration levels
  • Pharmacodynamics: PD-L1 expression levels on tumour, immune-filtrating cells
  • Efficacy [Best overall response rate, objective response rate, disease control rate, duration of objective response, progression-free survival] (composite outcome measure)
  • Overall survival

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