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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 Nivolumab 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 nivolumab

Primary Outcome 1 - Timeframe: 2.5 years

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

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