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A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04137536
Recruitment Status : Recruiting
First Posted : October 24, 2019
Last Update Posted : June 18, 2020
Sponsor:
Collaborator:
University of Virginia
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to find the safest dose and identify any bad side effects of EGFR-BATs (bispecific antibody-armed activated T cells) for people with advanced pancreatic cancer who have already received first-line standard chemotherapy.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Advanced Pancreatic Cancer Pancreatic Adenocarcinoma Pancreatic Neoplasms Drug: anti-EGFR-bispecific antibody armed activated T-cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ib Treatment of Advanced Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Bispecific Antibody Armed Activated T-Cells (BATs)
Actual Study Start Date : October 17, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pancreatic Adenocarcinoma
Participants have metastatic pancreatic cancer who have received at least first line chemotherapy and have disease progression during or within 6 months of treatment.
Drug: anti-EGFR-bispecific antibody armed activated T-cells

Phase I:

  • First 3 participants, twice weekly infusions of 10^10 EGFR BATs infusions
  • If there is toxicity in 0 or 1 of 3 participants, 3 additional participants will be added to the dose level of up to 10^10.
  • If >/= 2 of 6 participants experience DLTs, then the dose will be reduced to 7.5 x 10^9 per infusion
  • If only 0 or 1 participants has toxicity in the first 6, then the study will proceed to enroll in the expansion cohort

Expansion cohort:

- 8 infusions of 7.5 x 10^9 or 10^10 EGFR BATs in 22 evaluable participants (including the 6 participants treated at the maximum tolerated dose in Phase I)

Other Name: EGFR BATs




Primary Outcome Measures :
  1. Evaluate toxicity [ Time Frame: 1 year ]
    The NCI CTEP CTCAE v4.0 will be used.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytological proof of pancreatic adenocarcinoma. Must have metastatic pancreatic cancer who have received at least first line chemotherapy. Disease stability or progression during or within 6 months after treatment with 5-Fluorouracil (5-FU)- or gemcitabine-based chemotherapy. KPS>/= 70% or SWOG performance Status 0 or 1
  • Evaluable disease by iRECIST criteria
  • Absolute Neutrophil Count (ANC) >/= 1,000/mm^3
  • Lymphocyte count >/= 400/mm^3
  • Platelet Count >/= 75,000/mm^3
  • Hemoglobin >/= 8 g/dL
  • Serum Creatinine < 2.0 mg/dl, Creatinine Clearance >/=50 ml/mm (can be calculated or measured)
  • Total Bilirubin </= 2 mg/dl (biliary stent is allowed)
  • SGPT and SGOT <5.0 times normal
  • LVEF >/= 55% at rest (<UGA or Echo)
  • Age >/= 18 years at the time of consent (Written informed consent and HIPAA authorization for release of personal health information)
  • Females of childbearing potential, and males, must be willing to use an effective method of contraception
  • Females of childbearing potential must have a negative pregnancy test within 7 days of being registered for protocol therapy

Exclusion Criteria:

  • Any chemotherapy related toxicities from prior treatment, > grade 2 per CTCAE v4.0
  • Known hypersensitivity to cetuximab or other EGFR antibody
  • Treatment with any investigational agent within 14 days prior to being registered for protocol therapy
  • Symptomatic brain metastasis
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Steroid premedication for imaging scans is allowed. Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to being registered for protocol therapy
  • Active liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
  • Known HIV infection
  • Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed)
  • Has an active infection requiring systemic therapy
  • A serious uncontrolled medical disorder that in the opinion of the Investigator may be jeopardized by the treatment with protocol therapy.
  • Females must not be breastfeeding
  • Patient may be excluded if, in the opinion of the PI and investigator team, the patient is not capable of being compliant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04137536


Contacts
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Contact: Kenneth Yu, MD 646-888-4188 YuK1@mskcc.org
Contact: Eileen O'Reilly, MD 646-888-4182 oreillye@mskcc.org

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Kenneth Yu, MD    646-888-4188      
United States, Virginia
University of Virginia (Specimen Analysis) Not yet recruiting
Charlottesville, Virginia, United States, 22908
Contact: Lawrence Lum, MD, DSC    434-243-1375      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
University of Virginia
Investigators
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Principal Investigator: Kenneth Yu, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04137536    
Other Study ID Numbers: 18-463
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
EGFR-BAT
bispecific antibody-armed activated T cells
Pancreatic cancer
memorial sloan kettering cancer center
18-463
Additional relevant MeSH terms:
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Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antibodies
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs