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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
  • NTC 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
    Phase 1
  • 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

  • Endometrial Cancer
  • Esophageal Cancer
  • Esophagogastric Junction (EGJ)
  • Gastric (Stomach) Cancer
  • Head and Neck Cancer
  • Melanoma
  • Ovarian Cancer
  • Non-small Cell Lung (NSCLC)
  • Urothelial Cancer

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: 75 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: David Hong, MD

Role: Principal Investigator

Affiliation: M.D. Anderson Cancer Center

Overall Contact

Name: David Hong, MD

Phone: 713-563-5844

Email: dshong@madanderson.org

LOCATION

Facility Status Contact
Facility: Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Status: Recruiting Contact: Principal Investigator
Sajeve S Thomas, MD
617-643-3614 4846
dplawrence@mgh.harvard.edu
Facility: Washington University - School of Medicine
Saint Louis, Missouri 63110
United States
Status: Recruiting Contact: Contact
Donald P Lawrence
314-273-2726 2805
munschr@wustl.edu
Facility: Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Status: Recruiting Contact: Contact
Rebecca Munsch
919-668-6406
m.alex.guess@duke.edu
Facility: Duke University Medical Center, Duke Cancer Institute
Durham, North Carolina 27710
United States
Status: Recruiting Contact: Principal Investigator
Brian Van Tine, MD
405-271-8001
Silas-Day@ouhsc.edu
Facility: OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact: Contact
David Aggen, MD
615-329-7274
dshong@mdanderson.org
Facility: Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: Contact
Alex Guess
414-805-8342
genevieve.mendiola@uhn.ca
Facility: M.D. Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Principal Investigator
Jeffrey M Clarke, MD
416-634-7940
propuestasMI.hdoc@salud.madrid.org
Facility: Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Status: Recruiting Contact: Contact
Silas Day
+34 91 390 89 22
mponz@unav.es
Facility: Princess Margaret Cancer Centre
Toronto, Valencia 46010
Canada
Status: Recruiting Contact: Contact
David Hong, MD
0034 91 550 48 00
ciocc@startmadrid.com
Facility: Hospital Universitario 12 De Octubre
Madrid, 08035
Spain
Status: Recruiting Contact: Principal Investigator
David Hong, MD
91 756 78 25
espe.m.garcia@gmail.com
Facility: Clinica Universitaria de Navarra
Pio, 28040
Spain
Status: Recruiting Contact: Contact
Jessica Neumann
+34 600145696
Facility: Hospital Clinico de Valencia
Ibanez, 28050
Spain
Status: Recruiting Contact: Principal Investigator
John A Charlson, MD

Facility: Hospital Universitario Vall d'Hebron
Barcelona, 41013
Spain
Status: Recruiting Contact: Contact
Genevieve Mendiola

Facility: Hospital Universitario Fundacion Jimenez Diaz
Madrid,
Spain
Status: Recruiting Contact: Principal Investigator
Marcus Butler, MD

Facility: Hospital Universitario HM Sanchinarro CIOCC
Madrid,
Spain
Status: Recruiting Contact: Contact
Concha Hernandez

Facility: Hospital Universitario Virgen del Rocio
Sevilla,
Spain
Status: Recruiting Contact: Principal Investigator
Jon Zugazagoitia Fraile, MD