Vopratelimab and a CTLA-4 Inhibitor in PD-1/PD-L1 Inhibitor Experienced Subjects With NSCLC or Urothelial Cancer

Titre officiel

Phase 2 Multicentre Trial of ICOS Agonist Monoclonal Antibody (mAb) JTX -2011 and a CTLA-4 Inhibitor in PD-1/PD-L1 Inhibitor Experienced Adult Subjects With Non-small Cell Lung Cancer or Urothelial Cancer

Sommaire:

JTX-2011-201 is a Phase 2, open label clinical study of vopratelimab (JTX-2011) and ipilimumab in adult subjects with non-small cell lung cancer (NSCLC) or urothelial cancer to evaluate safety and efficacy.

Description de l'essai

Primary Outcome:

  • % subjects with overall response (OR)
Secondary Outcome:
  • % subjects with adverse events (AEs)
  • % subjects with serious adverse events (SAEs)
  • % subjects with clinically significant change from baseline in clinical laboratory tests
  • % subjects with anti-drug antibodies (ADA) to treatment
  • % of subjects with neutralizing antibodies (NAb) to treatment
  • % of subjects with clinically significant changes in electrocardiogram (ECG) measurements
  • Area under the serum concentration-time curve (AUC)
  • Maximum measured concentration in serum (Cmax)
  • Time from dosing to maximum measured concentration (tmax)
  • Terminal half-life (t1/2)
  • Total clearance of the analyte in serum (CL)
  • Apparent volume of distribution during specific time points
  • Median duration of response (DOR)
  • Disease control rate (DCR)
  • Landmark progression free survival (PFS)
  • Median PFS
  • Median overall survival (OS)
Vopratelimab is an agonist monoclonal antibody that specifically binds to the Inducible CO-Stimulator of T cells (ICOS) to generate an anti-tumour immune response. This is a Phase 2, open label study to evaluate the safety and efficacy of vopratelimab in combination with ipilimumab in adult subjects with advanced and/or refractory non-small cell lung cancer and urothelial cancer.

Voir cet essai sur ClinicalTrials.gov

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