Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of Selicrelumab (RO7009789) With Vanucizumab or Bevacizumab in Participants With 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, Part I) or Bevacizumab (Anti-VEGF Monoclonal Antibody, Part II) in Patients With Metastatic Solid Tumours

Summary:

This open-label, two-part study is designed to assess the safety, PK, PD, and therapeutic activity of Selicrelumab in combination with vanucizumab or bevacizumab 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 Selicrelumab in this combination. Part II (expansion) is intended to characterize the safety and tolerability of Selicrelumab in combination with bevacizumab among indication-specific cohorts and to confirm the recommended dose.

Trial Description

Primary Outcome:

  • Percentage of Participants With Dose-Limiting Toxicities (DLTs)
  • MTD of Selicrelumab in Combination With Vanucizumab
  • Recommended Phase II Dose of Selicrelumab in Combination With Vanucizumab
  • Percentage of Participants With Adverse Events (AEs)
  • Clinical Activity of SC Selicrelumab in Combination with Bevacizumab as Assessed by Response Evaluation in Solid Tumours, Version 1.1 (RECIST v1.1)
  • Clinical Activity of SC Selicrelumab in Combination with Bevacizumab as Assessed by Unidimensional Immune-Related Response Criteria (irRC)
Secondary Outcome:
  • Percentage of Participants With Anti-Drug Antibodies (ADAs) to Selicrelumab
  • Percentage of Participants with ADAs to Vanucizumab
  • Area Under the Concentration-Time Curve From Time 0 to Last Measureable Concentration (AUClast) of Selicrelumab Following Subcutaneous (SC) Administration
  • Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Selicrelumab Following SC Administration
  • Maximum Concentration (Cmax) of Selicrelumab Following SC Administration
  • Time to Maximum Concentration (Tmax) of Selicrelumab Following SC Administration
  • Apparent Clearance (CL/F) of Selicrelumab Following SC Administration
  • Apparent Volume of Distribution (Vd/F) of Selicrelumab Following SC Administration
  • Apparent Terminal Half-Life (t1/2) of Selicrelumab Following SC Administration
  • AUClast of Selicrelumab Following Intravenous (IV) Administration
  • AUCinf of Selicrelumab Following IV Administration
  • Cmax of Selicrelumab Following IV Administration
  • Minimum Concentration (Cmin) of Selicrelumab Following IV Administration
  • CL of Selicrelumab Following IV Administration
  • Volume of Distribution at Steady-State (Vss) of Selicrelumab Following IV Administration
  • t1/2 of Selicrelumab Following IV Administration
  • AUClast of Vanucizumab
  • AUCinf of Vanucizumab
  • Concentration at the End of Infusion (Cend) of Vanucizumab
  • CL of Vanucizumab
  • Vss of Vanucizumab
  • t1/2 of Vanucizumab
  • Change in Blood and Tumour Tissue Immune Cell Subpopulations
  • Change in Peripheral Blood Level of Cytokines
  • Change in Blood Soluble Proteins
  • Percentage of Participants With Best Overall Response per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) Criteria
  • Percentage of Participants With Best overall Response Immune-Related Response Criteria (irRC)
  • Duration of Objective Response per RECIST v1.1 Criteria
  • Duration of Objective Response per irRC
  • Percentage of Participants With Disease Control per RECIST v1.1 Criteria
  • Percentage of Participants With Disease Control per irRC
  • Progression-free Survival (PFS) per RECIST v1.1 Criteria
  • PFS per irRC
  • Overall Survival (OS)
  • Concentration at the end of Infusion (Cend) of Bevacizumab
  • Minimum Concentration (Cmin) of Bevacizumab after Infusion

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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