ADP-A2M4CD8 as Monotherapy or in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumours (SURPASS)

Official Title

A Phase 1 Dose Escalation Study To Assess Safety And Efficacy Of ADP-A2M4CD8 As Monotherapy Or In Combination With Nivolumab In HLA-A2+ Subjects With MAGE-A4 Positive Tumours (SURPASS)

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 MAGE-A4 tumour antigen. Tumour indications include endometrial, esophageal, esophagogastric junction (EGJ), gastric, head and neck, melanoma, non-small cell lung (NSCLC), ovarian or urothelial cancer.

Trial Description

Primary Outcome:

• To evaluate safety and tolerability of ADP-A2M4CD8 as monotherapy or in combination with nivolumab
• To evaluate safety of ADP-A2M4CD8 as monotherapy or in combination with nivolumab

Secondary Outcome:

• 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)

Conditions: Endometrial Esophageal Cancer Esophagogastric Junction (EGJ) Gastric (stomach) Head and Neck Melanoma Non-small Cell Lung (NSCLC) Ovarian Cancer

View this trial on ClinicalTrials.gov