Surpass: ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Tumours

Official Title

A Phase 1 Dose Escalation Study To Assess Safety And Efficacy Of ADP-A2M4CD8 In HLA-A2+ Subjects With MAGE-A4 Positive Tumours

Summary:

This study will investigate the safety and tolerability of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumour antigen status and whose urothelial, head and neck, gastric (stomach), esophagogastric junction (EGJ), non-small cell lung (NSCLC), or esophageal cancer that express the MAGE-A4 protein.

Trial Description

Primary 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
• Evaluate safety of ADP-A2M4CD8 through measurement of Replication -competent Retrovirus in genetically engineered T-cells

• Anti-tumour activity: Overall Response Rate (ORR)
• Anti-tumour activity: Best overall response (BOR)
• Time to response (TTR)
• Duration of Response (DOR)
• Duration of stable disease (DoSD)
• Progression Free Survival (PFS)
• Overall Survival (OS)

View this trial on ClinicalTrials.gov