Sym021 Monotherapy, in Combination With Sym022 or Sym023, and in Combination With Both Sym022 and 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, in Combination With Either Sym022 (Anti-LAG-3) or Sym023 (Anti-TIM-3), and in Combination With Both Sym022 and Sym023 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.
  • Part 3: 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 safety, tolerability, and dose-limiting toxicities (DLTs) to establish the maximum tolerated dose (MTD) and/or the selected dose of sequential escalating doses of Sym021 when administered once every 2 weeks (Q2W) by IV infusion to patient cohorts with locally advanced/unresectable or metastatic solid tumour malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available Part 2 of the study will evaluate the safety, tolerability, and DLTs to establish the MTD and/or the selected dose of sequential escalating doses of Sym022 when administered Q2W in combination with a fixed dose of 3 mg/kg of Sym021, each by IV infusion to patient cohorts with locally advanced/unresectable or metastatic solid tumour malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available Part 3 of the study will evaluate of the safety, tolerability, and DLTs to establish the MTD and/or the selected dose of sequential escalating doses of Sym023 when administered Q2W in combination with fixed doses of 3 mg/kg of Sym021 and either 1, 3 or 5 mg/kg of Sym022, each by IV infusion to patient cohorts with locally advanced/unresectable or metastatic solid tumour malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available.

Voir cet essai sur ClinicalTrials.gov

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