Sym021 Monotherapy and in Combination With Sym022 or Sym023 in Patients With Advanced Solid Tumour Malignancies or Lymphomas

Titre officiel

A Phase 1, Open-Label, Multicentre Trial Investigating the Safety, Tolerability, and Preliminary Antineoplastic Activity of Sym021 (Anti-PD-1) as Monotherapy and in Combination With Either Sym022 (Anti-LAG-3) or Sym023 (Anti-TIM-3) in Patients With Advanced Solid Tumour Malignancies or Lymphomas

Sommaire:

Il s’agit de la première étude chez l’humain portant sur le Sym021. Le principal objectif de cette étude est d’évaluer l’innocuité et la tolérabilité du Sym021 chez des patients atteints de tumeurs malignes solides localement avancées/non résécables ou métastatiques ou de lymphomes réfractaires aux traitements existants ou pour lesquels il n’existe aucun traitement de référence.

Description de l'essai

Primary Outcome:

  • Part 1: Assessment of treatment emergent adverse events (AEs) meeting DLT criteria.
  • Part 2: Assessment of treatment emergent adverse events (AEs) meeting DLT criteria.
Secondary Outcome:
  • Evaluation of the immunogenicity of Sym021 as a single agent and in combination with Sym022 and Sym023.
  • Evaluation of objective response (OR) or stable disease (SD).
  • Time to progression (TTP) of disease.
  • Area under the concentration-time curve in a dosing interval (AUC)
  • Maximum concentration (Cmax)
  • Time to reach maximum concentration (Tmax)
  • Trough concentration (Ctrough)
  • Terminal elimination half-life (T½)
  • Clearance (CL)
Part 1 of this study will evaluate the preliminary safety, tolerability, and dose-limiting toxicities (DLTs) of Sym021, an anti-programmed cell death protein 1 (PD-1) monoclonal antibody (mAb). The goal is to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of sequential escalating doses of Sym021 when administered once every 2 weeks (Q2W) by 30-minute intravenous (IV) infusion. Sym021 will be given to patients in escalating dose cohorts; each patient will be given one fixed dose level. Part 2 of this study will evaluate the safety, tolerability, and DLTs to establish the MTD and/or RP2D of sequential escalating doses of Sym022 and Sym023 when administered Q2W in combination with the RP2D of Sym021, each by IV infusion. Dose levels of Sym021+Sym022 and Sym021+Sym023 will be evaluated until for each combination the MTD is identified, a maximum administered dose (MAD) is reached, or until a RP2D for the added mAb (Sym022 or Sym023) in combination with Sym021 is selected. Each patient will be given one fixed dose level of an assigned combination.

Voir cet essai sur ClinicalTrials.gov

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