Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumour Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment

Titre officiel

An Open-Label, Multicentre, Phase Ib Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumour Activity Of RO7122290, A Fibroblast Activation Protein-A (FAP) Targeted 4-1BB Ligand (CD137L), In Combination With Cibisatamab With Obinutuzumab Pre-Treatment, In Participants With Previously Treated, Metastatic, Microsatellite-stable Colorectal Adenocarcinoma With High CEACAM5 Expression

Sommaire:

Il s’agit d’une étude multicentrique ouverte de phase Ib visant à déterminer la dose maximale tolérée (DMT) et/ou la dose recommandée pour la phase II (DRP2) à utiliser dans un schéma thérapeutique administré toutes les semaines et/ou toutes les 3 semaines ainsi que l’innocuité, la tolérabilité, la pharmacocinétique, la pharmacodynamique, l’immunogénicité et l’activité antitumorale préliminaire du RO7122290 en association avec le cibisatamab administré toutes les 3 semaines après un traitement préalable par l’obinutuzumab chez des participants atteints d’un adénocarcinome colorectal métastatique avec stabilité microsatellitaire surexprimant le CEACAM5 et ayant déjà été traité.

Description de l'essai

Primary Outcome:

  • Part I: Occurrence of dose-limiting toxicities
  • Percentage of Participants with Adverse Events
Secondary Outcome:
  • Serum concentration of RO7122290 over time
  • Plasma concentration of RO7122290 over time
  • Maximum concentration (Cmax) of RO7122290
  • Time of maximum concentration (Tmax) of RO7122290
  • Clearance (CL) of RO7122290
  • Volume of distribution (V) of RO7122290
  • Area under the curve (AUC) of RO7122290
  • Half-life (t1/2) of RO7122290
  • Serum concentration of Cibisatamab over time
  • Plasma concentration of Cibisatamab over time
  • Maximum concentration (Cmax) of Cibisatamab
  • Time of maximum concentration (Tmax) of Cibisatamab
  • Clearance (CL) of Cibisatamab
  • Volume of distribution (V) of Cibisatamab
  • Area under the curve (AUC) of Cibisatamab
  • Half-life (t1/2) of Cibisatamab
  • Serum concentration of Obinutuzumab over time
  • Plasma concentration of Obinutuzumab over time
  • Maximum concentration (Cmax) of Obinutuzumab
  • Time of maximum concentration (Tmax) of Obinutuzumab
  • Clearance (CL) of Obinutuzumab
  • Volume of distribution (V) of Obinutuzumab
  • Area under the curve (AUC) of Obinutuzumab
  • Half-life (t1/2) of Obinutuzumab
  • Percentage of Participants with RO7122290 anti-drug antibodies (ADAs) during the study relative to the prevalence of ADA at baseline
  • Percentage of Participants with Cibisatamab anti-drug antibodies (ADAs) during the study relative to the prevalence of ADA at baseline
  • Percentage of Participants with Obinutuzumab anti-drug antibodies (ADAs) during the study relative to the prevalence of ADA at baseline
  • Treatment-induced change on T-cell proliferation (CD8/Ki67)
  • Treatment-induced change on T-cell activation (CD8/4-1BB)
  • Treatment-induced change on tumour necrosis factor alpha (TNF-alpha) levels
  • Treatment-induced change on interferon gamma (IFN-gamma) levels
  • Treatment-induced change on Interleukin (IL)-2 levels
  • Treatment-induced change on Interleukin (IL)-6 levels
  • Treatment-induced change on Interleukin (IL)-8 levels
  • Treatment-induced change on Interleukin (IL)-10 levels
  • Treatment-induced change on Granulocyte-macrophage colony-stimulating factor (GM-CSF) levels
  • Objective response rate (ORR) defined as complete response (CR) + partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1
  • Disease control rate (DCR); defined as response rate (RR) + stable disease (SD) according to the Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1
  • Duration of response (DoR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1
  • Progression-free survival (PFS) according to the Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1
  • Change on CEACAM5 tumour expression levels
  • Change on CEA tumour expression levels
  • Change on FAP tumour expression levels
  • Change on 4-1BB tumour expression levels

Voir cet essai sur ClinicalTrials.gov

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