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

Titre officiel

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

Sommaire:

Cette étude en deux parties et à mode ouvert est conçue pour évaluer l'innocuité, la pharmacocinétique, la pharmacodynamique et l'activité thérapeutique du RO7009789 en combinaison avec le vanucizumab chez des participants présentant des tumeurs solides métastatiques ne se prêtant pas à un traitement standard. La partie I (escalade de dose) est conçue pour fixer la dose maximale tolérée (DMT) de RO7009789 dans cette combinaison. La partie II (expansion) vise à mieux caractériser le profil d'innocuité et d'activité clinique du RO7009789 dans des cohortes formées selon l'indication.

Description de l'essai

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

Voir cet essai sur ClinicalTrials.gov

Intéressé(e) par cet essai?

Imprimez cette page et apportez-la chez votre médecin pour discuter de votre admissibilité à cet essai et des options de traitement. Seul votre médecin peut vous recommander pour un essai clinique.

Ressources

Société canadienne du cancer

Ces ressources sont fournies en partenariat avec Société canadienne du cancer