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ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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

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)

NCT04044859•USWM CT, LLC

View on ClinicalTrials.gov

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

Detailed Description

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥18 and ≤ 75 years
•Subject is positive for at least 1 HLA-A\*02 inclusion allele
•Histologically or cytogenetically confirmed diagnosis of urothelial cancer, esophageal, esophagogastric junction (EGJ) cancer, gastric cancer, non-small cell lung carcinoma (NSCLC), head and neck or ovarian cancer, endometrial cancer, melanoma
•Measurable disease according to RECIST v1.1 prior to leukapheresis and lymphodepletion.
•Tumor shows MAGE-A4 expression as confirmed by central laboratory
•ECOG Performance Status of 0 or 1.

Exclusion Criteria

•Subjects must have ≥ 90% room air oxygen saturation at rest at Screening (within 7 days of leukapheresis) and at Baseline.
•Positive for any HLA-A\*02 allele other than: one of the inclusion alleles
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study
•Active autoimmune or immune mediated disease
•Leptomeningeal disease, carcinomatous meningitis or symptomatic CNS metastases
•Other prior malignancy that is not considered by the Investigator to be in complete remission. Clinically significant cardiovascular disease
•Uncontrolled intercurrent illness
•Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus
•Pregnant or breastfeeding

Locations (17)

Name of Institution: Orlando Health Cancer Institute

Orlando, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Washington University - School of Medicine

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University Medical Center, Duke Cancer Institute

Durham, North Carolina, United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

M.D. Anderson Cancer Center

Houston, Texas, United States

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Key Dates

Start Date

August 20, 2019

Primary Completion Date

April 23, 2026

Completion Date

April 30, 2037

Last Updated

February 9, 2026

Enrollment

120

ESTIMATED participants

Conditions

Endometrial CancerEsophageal CancerEsophagogastric Junction (EGJ)Gastric (Stomach) CancerHead and Neck CancerMelanomaOvarian CancerNon-small Cell Lung (NSCLC)Urothelial Cancer

Interventions

Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks

GENETIC

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

NCT05489211

Endometrial CancerGastric Cancer+5 more

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RECRUITINGPHASE1/PHASE2

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068

Advanced CancerMetastatic Cancer+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Resilience and Equity in Aging, Cancer, and Health (REACH)

Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.

Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Gastroesophageal Cancers

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors