A Study Evaluating Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281 as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)

Titre officiel

An Open-Label, Multicentre, Dose-Escalation, Phase Ia/Ib Study to Evaluate Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281, an Immunocytokine Consisting of Interleukin 2 Variant (IL-2v) Targeting Fibroblast Activation Protein-α (FAP), as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)

Sommaire:

Cette étude multicentrique de phase Ia/Ib, ouverte, adaptative et à doses multiples croissantes menée pour la première fois chez l’humain vise à évaluer l’innocuité, la tolérabilité, la pharmacocinétique, la pharmacodynamique et l’activité antitumorale préliminaire du RO6874281 en monothérapie (partie A) ou en association avec le trastuzumab ou le cétuximab (partie B ou C).

Description de l'essai

Primary Outcome:

  • Percentage of Participants With Dose-Limiting Toxicities (DLTs)
  • Maximum Tolerated Dose (MTD) of RO6874281
  • Optimal Biological Dose (OBD) of RO6874281
  • Recommended Dose for Further Development of RO6874281
  • Systemic Clearance (CL) of RO6874281
  • Volume of Distribution at Steady State (Vss) of RO6874281
  • Area Under the Concentration-Time Curve (AUC) of RO6874281
  • Maximum Observed Serum Concentration (Cmax) of RO6874281
Secondary Outcome:
  • Number of T Cells in the Peripheral Blood
  • Number of Natural Killer (NK) Cells in the Peripheral Blood
  • Density of Cluster of Differentiation (CD)8+ Cells in Tumour Samples
  • Density of CD3-/Perforin+ Cells in Tumour Samples
  • Density of CD20 Cells in Tumour Samples
  • Percentage of Participants With Overall Response According to Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1)
  • Percentage of Participants With Disease Control According to RECIST v1.1
  • Progression-Free Survival (PFS) According to RECIST v1.1
  • Percentage of Participants With Overall Response According to Modified RECIST
  • Percentage of Participants With Disease Control According to Modified RECIST
  • PFS According to Modified RECIST
  • Percentage of Participants With Overall Response According to iRECIST
  • Percentage of Participants With Disease Control According to iRECIST
  • PFS According to iRECIST

Voir cet essai sur ClinicalTrials.gov

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