ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)

Titre officiel

A Phase 2 Open-Label Clinical Trial of ADP-A2M4CD8 in Subjects With Advanced Esophageal or Esophagogastric Junction Cancers

Sommaire:

This study will investigate the efficacy of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumour antigen status and whose esophageal or esophagogastric junction (EGJ) cancer expresses the MAGE-A4 protein.

Description de l'essai

Primary Outcome:

  • Efficacy: Overall Response Rate (ORR)
Secondary Outcome:
  • Number of subjects with treatment -related adverse events (AEs), including serious adverse events (SAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
  • Efficacy: Best overall response (BOR)
  • Time to response (TTR)
  • Duration of Response (DoR)
  • Progression Free Survival (PFS)
  • Overall Survival (OS)
  • Invitro diagnostic (IVD) assay for screening
  • Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs

Voir cet essai sur ClinicalTrials.gov

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