Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of RO7009789 With Vanucizumab 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) 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 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)
  • MTD of RO7009789 in Combination With Vanucizumab
  • Recommended Phase II Dose of RO7009789 in Combination With Vanucizumab
  • 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 From Time 0 to Last Measureable Concentration (AUClast) of RO7009789 Following Subcutaneous (SC) Administration
  • Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of RO7009789 Following SC Administration
  • Maximum Concentration (Cmax) of RO7009789 Following SC Administration
  • Time to Maximum Concentration (Tmax) of RO7009789 Following SC Administration
  • Apparent Clearance (CL/F) of RO7009789 Following SC Administration
  • Apparent Volume of Distribution (Vd/F) of RO7009789 Following SC Administration
  • Apparent Terminal Half-Life (t1/2) of RO7009789 Following SC Administration
  • AUClast of RO7009789 Following Intravenous (IV) Administration
  • AUCinf of RO7009789 Following IV Administration
  • Cmax of RO7009789 Following IV Administration
  • Minimum Concentration (Cmin) of RO7009789 Following IV Administration
  • CL of RO7009789 Following IV Administration
  • Volume of Distribution at Steady-State (Vss) of RO7009789 Following IV Administration
  • t1/2 of RO7009789 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)

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