Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of RO7009789 With Vanucizumab in Metastatic Solid Tumours

Official Title

An Open-Label, Multicentre, Dose Escalation Phase Ib Study With Expansion Cohorts to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Therapeutic Activity of RO7009789 (CD40 Agonistic Monoclonal Antibody) in Combination With Vanucizumab (Anti-Ang2 and Anti-VEGF Bi-Specific Monoclonal Antibody) in Patients With Metastatic Solid Tumours


This open-label, two-part study is designed to assess the safety, PK, PD, and therapeutic activity of RO7009789 in combination with vanucizumab in participants with metastatic solid tumours not amenable to standard treatment. Part I (dose escalation) is designed to establish the maximum tolerated dose (MTD) of RO7009789 in this combination. Part II (expansion) is intended to further characterize the safety and clinical activity profile of RO7009789 among indication-specific cohorts.

Trial Description

Primary Outcome:

  • Percentage of participants with dose-limiting toxicities (DLTs)
  • Percentage of participants with adverse events (AEs)
Secondary Outcome:
  • Percentage of participants with anti-drug antibodies (ADAs) to RO7009789
  • Percentage of participants with ADAs to vanucizumab
  • Area under the concentration-time curve (AUC) of RO7009789
  • Maximum concentration (Cmax) of RO7009789
  • Time to maximum concentration (Tmax) of RO7009789
  • Apparent clearance (CL) of RO7009789
  • Volume of distribution (Vd) of RO7009789
  • Apparent terminal half-life (t1/2) of RO7009789
  • AUC of vanucizumab
  • Concentration at the end of infusion (Cend) of vanucizumab
  • CL of vanucizumab
  • Vd of vanucizumab
  • t1/2 of vanucizumab
  • Change in blood and tumour tissue immune cell subpopulations, as available
  • Change in peripheral blood level of cytokines, as available
  • Change in blood soluble proteins, as available
  • Percentage of participants with objective response per Response Evaluation Criteria in Solid Tumours (RECIST) and immune-related response criteria (irRC)
  • Duration of objective response per RECIST and irRC
  • Percentage of participants with disease control per RECIST and irRC
  • Duration of progression-free survival (PFS) per RECIST and irRC
  • Duration of overall survival (OS)

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