A Phase I Study of ADP-A2M4CD8 with or without Nivolumab Immunotherapy in People with Urothelial Cancer, Non-Small Cell Lung Cancer, or Endometrial Cancer


Full Title

A Phase 1 Dose Escalation Study to Assess Safety and Efficacy of ADP-A2M4CD8 As Monotherapy Or In Combination With Either Nivolumab Or Pembrolizumab in HLA-A2+ Subjects with MAGE-A4 Positive Tumors (Surpass Study, ADP-0055-001)


The purpose of this study is to assess the safety and effectiveness of giving the investigational drug ADP-A2M4CD8 with and without nivolumab immunotherapy in people with urothelial cancer, non-small cell lung cancer (NSCLC), or endometrial cancer that is not responding to treatment or has spread. In addition, their cancers must contain proteins called HLA and MAGE-A4.

ADP-A2M4CD8 is a type of cellular therapy made from each patient’s own white blood cells called T cells. Researchers will collect a sample of their T cells and send them to a laboratory, where they will be trained to target cells containing MAGE-A4. This targeting action may help ADP-A2M4CD8 find cancer cells and kill them. Nivolumab works by boosting the power of the immune system to detect and destroy cancer cells. The treatments in this study are given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have urothelial cancer, NSCLC, or endometrial cancer that is not responding to treatment or has spread.
  • Patients’ cancers must contain the HLA and MAGE-A4 proteins.
  • The serious side effects of prior therapies must go away before the study treatment is given.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people ages 18-75.


For more information and to ask about eligibility for this study, please contact the office of Dr. David Aggen at 646-422-4679.




Phase I (phase 1)



ClinicalTrials.gov ID