Evaluation of SAR408701 in Patients With Advanced Solid Tumours

Titre officiel

A First-in-Human Study for the Evaluation of the Safety, Pharmacokinetics and Antitumour Activity of SAR408701 in Patients With Advanced Solid Tumours

Sommaire:

Objectifs principaux : Déterminer la dose maximale tolérée (DMT) du SAR408701 administré sous forme de monothérapie aux patients atteints de tumeurs solides à un stade avancé (Phase d'escalade). Évaluer l'efficacité selon les Critères d'évaluation de la réponse tumorale, version 1.1 chez les patients atteints de tumeurs solides (RECIST 1.1) (Phase d'expansion). Objectifs secondaires : Caractériser le profil global de l'innocuité du SAR408701. Caractériser le profil pharmacocinétique (PK) du SAR408701 et de ses dérivés circulants potentiels. Identifier la dose recommandée de phase 2 (DRP2) du SAR408701. Évaluer l'immunogénicité potentielle du SAR408701.

 

Description de l'essai

Primary Outcome:

  • Number of dose limiting adverse events (every 2 week cycle)
  • Assessment of overall response rate using standard imaging and RECIST 1.1 criteria
  • Number of dose limiting adverse events (every 3 week cycle)
Secondary Outcome:
  • Number of treatment emergent adverse events
  • Maximum concentration (Cmax)
  • Time to reach maximum concentration (tmax)
  • Trough plasma concentrations (Ctrough)
  • Area under the plasma concentration versus time curve between 0 and 14 days (AUC0-14day) for Q2W or between 0 and 21 days (AUC-21 day) for Q3W
  • Mean systemic clearance (CL)
  • Clearance at steady state (CLss)
  • Accumulation ratio (Rac) on AUC0-14day and Cmax
  • Detection of the development of anti-SAR408701 antibody
  • Duration of response
  • Time to Progression
The study duration for an individual patient will start from the signature of the informed consent, will include a period to assess eligibility (screening period) of up to approximately 4 weeks (28 days), a treatment period and an end-of-treatment visit around 30 days following the last administration of study drug, and at least one follow-up visit after the end-of-treatment visit. Additional follow-up visits may be required until resolution or stabilization of adverse events (at least 30 days). Treatment may continue until precluded by toxicity, progression, or upon patient's request. If the patient stops study treatment for reason other than disease progression, follow-up visit will be performed every 3 months until disease progression or initiation of another anti-tumour treatment or death, whichever comes first.

Voir cet essai sur ClinicalTrials.gov

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