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Brief Title: Surpass: ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Tumors

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)

INTRODUCTION

  • Org Study ID: ADP-0055-001
  • Secondary ID: N/A
  • NCT ID: NCT04044859
  • Sponsor: Adaptimmune

BRIEF 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

  • Overall Status
    Recruiting
  • Start Date
    August 20, 2019
  • Phase
    P
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: To evaluate safety and tolerability of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab

Primary Outcome 1 - Timeframe: 2.5 years

Primary Outcome 2 - Measure: To evaluate safety of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab

Primary Outcome 2 - Timeframe: Up to 15 years

CONDITION

  • E
  • E
  • E
  • G
  • H
  • M
  • O
  • N
  • U

ELIGIBILITY

* Key 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.

- * Left ventricular ejection fraction (LVEF) ≥50% or the institutional lower limit of normal range, whichever is lower Note: other protocol defined Inclusion/Exclusion criteria may apply

- * Subjects must have ≥ 90% room air oxygen saturation at rest at Screening (within 7 days of leukapheresis) and at Baseline.
Key exclusion criteria
* 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
Note: other protocol defined Inclusion/Exclusion criteria may apply.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: D

Role: P

Affiliation: M

Overall Contact

Name: D

Phone: 7

Email: d

LOCATION

Facility Status Contact
Facility: Name of Institution: Orlando Health Cancer Institute
Orlando, Florida 32806
United States
Status: Recruiting Contact: Contact
Sajeve S Thomas, MD
321-841-6780
sajeve.thomas@orlandohealth.com

Principal Investigator
Sajeve S Thomas, MD

Facility: Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Status: Recruiting Contact: Contact
Donald P Lawrence
617-643-3614
dplawrence@mgh.harvard.edu

Principal Investigator
Donald Lawrence, MD

Facility: Washington University - School of Medicine
Saint Louis, Missouri 63110
United States
Status: Recruiting Contact: Contact
Rebecca Munsch
314-273-2726
munschr@wustl.edu

Principal Investigator
Brian Van Tine, MD

Facility: Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Status: Recruiting Contact: Contact
David Aggen, MD
646-608-2091
cart@mskcc.org

Principal Investigator
David Aggen, MD

Facility: Duke University Medical Center, Duke Cancer Institute
Durham, North Carolina 27710
United States
Status: Recruiting Contact: Contact
Alex Guess
919-668-6406
m.alex.guess@duke.edu

Principal Investigator
Jeffrey M Clarke, MD

Facility: OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact: Contact
Silas Day
405-271-8001
48748
Silas-Day@ouhsc.edu

Principal Investigator
Adam Asch

Facility: Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: Contact
Nurse Navigators
615-329-7274

Principal Investigator
Melissa L Johnson, MD

Facility: M.D. Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
David Hong, MD
713-563-1930
dshong@mdanderson.org

Principal Investigator
David Hong, MD

Facility: Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Status: Recruiting Contact: Contact
Jessica Neumann
414-805-8342
jneumann@mcw.edu

Principal Investigator
John A Charlson, MD