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Trial record 2 of 4 for:    wilky

Safety and Efficacy of IMCnyeso in Advanced NY-ESO-1 and/or LAGE-1A Positive Cancers

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ClinicalTrials.gov Identifier: NCT03515551
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Immunocore Ltd

Brief Summary:
IMCnyeso is a new biological therapy designed for the treatment of cancers which express NY-ESO-1 and/or LAGE-1A. This is a first-in-human trial designed to evaluate the safety and efficacy of IMCnyeso in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for NY-ESO-1 and/or LAGE-A1.

Condition or disease Intervention/treatment Phase
Select Advanced Solid Tumors Drug: IMCnyeso Phase 1 Phase 2

Detailed Description:
This is a multi-center, open label, dose finding Phase 1/2 study of single agent IMCnyeso administered in patients with NY-ESO-1 and/or LAGE-A1 positive tumors. The primary objective of the dose escalation phase (Arm 1) is to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of IMCnyeso in patients with advanced solid tumors. Preliminary efficacy will be evaluated in Arm 2.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of IMCnyeso, HLA- A*0201-Restricted, NY-ESO-1- and LAGE-1A-specific Soluble T Cell Receptor and Anti-CD3 Bispecific Molecule, in HLA-A*0201 Positive Patients With Advanced NY-ESO-1 and/or LAGE - 1A Positive Cancer
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: IMCnyeso dose Escalation Phase with approximately 4-10 cohorts
Phase (Arm 1) n=approximately 27 patients to establish the MTD/RP2D
Drug: IMCnyeso
Weekly IV infusions of IMCnyeso

Experimental: IMCnyeso expansion with 3 cohorts
n=9-24/cohort treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso
Drug: IMCnyeso
Weekly IV infusions of IMCnyeso




Primary Outcome Measures :
  1. Phase I: Incidence of dose-limiting toxicities (DLT) [ Time Frame: from first dose to end of DLT period (up until Day 28 after first dose) ]
  2. Phase I: incidence and severity of adverse events (AE) [ Time Frame: from first dose to 30 days after the last dose ]
  3. Phase I: changes in laboratory parameters [ Time Frame: from first dose to 30 days after the last dose ]
    Abnormalities will be classified according to NCI CTCAE version 4.03

  4. Phase I: changes in body temperature [ Time Frame: from first dose to 30 days after the last dose ]
    Body temperature will be measured throughout the study. Both absolute values and changes from Baseline will be reported.

  5. Phase I: changes in pulse [ Time Frame: from first dose to 30 days after the last dose ]
    Pulse will be measured throughout the study. Both absolute values and changes from Baseline will be reported.

  6. Phase I: changes in respiratory rate [ Time Frame: from first dose to 30 days after the last dose ]
    Respiratory rate will be measured throughout the study. Both absolute values and changes from Baseline will be reported.

  7. Phase I: changes in blood pressure [ Time Frame: from first dose to 30 days after the last dose ]
    Blood pressure will be measured throughout the study. Both absolute values and changes from Baseline will be reported.

  8. Phase I: changes in electrocardiogram parameters [ Time Frame: from first dose to 30 days after the last dose ]
    QTcF interval absolute values and changes from Baseline

  9. Phase I: dose interruptions, reductions, and discontinuations [ Time Frame: from first dose through last dose (anticipated up to 1 year) ]
    Tolerability of study treatment will be assessed by summarizing the number of treatment dose interruptions and dose reductions.

  10. Phase II: Best overall response (BOR) [ Time Frame: from first dose to approximately 2 years ]

Secondary Outcome Measures :
  1. Phase II: incidence and severity of adverse events (AE) [ Time Frame: first dose to 30 days after the last dose ]
  2. Phase II: changes in laboratory parameters [ Time Frame: from first dose to 30 days after the last dose ]
    Abnormalities will be classified according to NCI CTCAE version 4.03

  3. Phase II: changes in body temperature [ Time Frame: from first dose to 30 days after the last dose ]
    Body temperature will be measured throughout the study. Both absolute values and changes from Baseline will be reported.

  4. Phase II: changes in pulse [ Time Frame: from first dose to 30 days after the last dose ]
    Pulse will be measured throughout the study. Both absolute values and changes from Baseline will be reported.

  5. Phase II: changes in respiratory rate [ Time Frame: from first dose to 30 days after the last dose ]
    Respiratory rate will be measured throughout the study. Both absolute values and changes from Baseline will be reported.

  6. Phase II: changes in blood pressure [ Time Frame: from first dose to 30 days after the last dose ]
    Blood pressure will be measured throughout the study. Both absolute values and changes from Baseline will be reported.

  7. Phase II: changes in electrocardiogram parameters [ Time Frame: from first dose to 30 days after the last dose ]
    QTcF interval absolute values and changes from Baseline

  8. Phase II: dose interruptions, reductions, and discontinuations [ Time Frame: first dose through last dose (anticipated up to 1 year) ]
    Tolerability of study treatment will be assessed by summarizing the number of treatment dose interruptions and dose reductions.

  9. Phase I: Best overall response (BOR) [ Time Frame: from first dose to approximately 2 years ]
  10. Progression-free survival [ Time Frame: from first dose to approximately 2 years ]
  11. Duration of response [ Time Frame: from first dose to approximately 2 years ]
  12. Overall survival [ Time Frame: from first dose to approximately 2 years ]
  13. Pharmacokinetics Area under the plasma concentration-time curve (AUC) [ Time Frame: 2 weeks (AUC will be assessed weekly for 2 weeks) ]
  14. Pharmacokinetics The maximum observed plasma drug concentration after single dose administration (Cmax) [ Time Frame: 2 weeks (AUC will be assessed weekly for 2 weeks) ]
  15. Pharmacokinetics The time to reach maximum plasma concentration (Tmax) [ Time Frame: 2 weeks (AUC will be assessed weekly for 2 weeks) ]
  16. Pharmacokinetics The elimination half-life (t1/2) [ Time Frame: 2 weeks (AUC will be assessed weekly for 2 weeks) ]
  17. Immunogenicity the incidence of anti-IMCnyeso antibody formation Immunogenicity the incidence of anti-IMCnyeso antibody formation [ Time Frame: 2 weeks (AUC will be assessed weekly for 2 weeks) ]


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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:

  1. HLA-A*0201 positive
  2. NY-ESO-1 and/or LAGE-1A positive tumor
  3. ECOG PS 0 or 1
  4. Selected advanced solid tumors
  5. Relapsed from, refractory to, or intolerant of standard therapy
  6. Measurable disease per RECIST v1.1
  7. If applicable, must agree to use highly effective contraception

Exclusion Criteria:

  1. Symptomatic or untreated central nervous system metastasis
  2. Inadequate washout from prior anticancer therapy
  3. Significant ongoing toxicity from prior anticancer treatment
  4. Impaired baseline organ function as evaluated by out-of-range laboratory values
  5. Clinically significant cardiac disease
  6. Active infection requiring systemic antibiotic therapy
  7. Known history of human immunodeficiency virus (HIV)
  8. Active hepatitis B virus (HBV) or hepatitis C virus (HCV)
  9. Ongoing treatment with systemic steroids or other immunosuppressive therapies
  10. Significant secondary malignancy
  11. Pregnancy or lactation

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): NCT03515551


Contacts
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Contact: Shannon Marshall 484-534-5261 clinicaltrials@immunocore.com
Contact: Meggan Tammaro 484-534-5261 Clinicaltrials@immunocore.com

Locations
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United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Breelyn Wilky, MD    303-724-6429      
Principal Investigator: Breelyn Wilky, MD         
United States, Florida
H Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Mihaela Druta, MD    813-745-3242      
Principal Investigator: Mihaela Druta, MD         
United States, Iowa
University of Iowa Hospital and Clinics Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Mohammed Milhem    319-356-2324      
Principal Investigator: Mohammed Milhem, MD         
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Detroit, Michigan, United States, 48201
Contact: Shirish Gadgeel, MD    313-576-8753      
Principal Investigator: Shirish Gadgeel, MD         
United States, Missouri
Washington University School of Medicine in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Brian Van Tine, MD    314-747-3096      
Principal Investigator: Brian Van Tine, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Sandra D'Angelo, MD    646-888-4159      
Contact: Sandra D'Angelo, MD         
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Takami Sato, MD    215-955-8874      
Principal Investigator: Takami Sato, MD         
UPMC - Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Melissa Burgess, MD    412-647-2811      
Principal Investigator: Melissa Burgess, MD         
United States, Tennessee
Tennessee Oncology NASH - SCRI Not yet recruiting
Nashville, Tennessee, United States, 37203
Contact: Melissa Johnson    615-329-7274      
Principal Investigator: Melissa Johnson, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jordi Rodon Ahnert, MD    713-792-5603      
Principal Investigator: Jordi Rodon Ahnert, MD         
United States, Utah
Huntsman Cancer Institute at The University of Utah Not yet recruiting
Salt Lake City, Utah, United States, 84132
Contact: Sumati Gupta    801-585-0303      
Principal Investigator: Sumati Gupta, MD         
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Marcus Butler    4169464501 ext 2003      
Principal Investigator: Marcus Butler         
United Kingdom
Sarah Cannon Research Institute UK Recruiting
London, United Kingdom, W1G 6AD
Contact: Hendrik Tobias Arkenau, MD    (440) 203-2195 x239      
Principal Investigator: Hendrik Tobias Arkenau, MD         
The Christie Hospital Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Fiona Thistlethwaite, MD         
Contact    +44 (0) 161 9182323      
Principal Investigator: Fiona Thistlethwaite, MD         
Royal Marsden Hospital Recruiting
Sutton, United Kingdom, SW3 6JJ
Contact: Juanita Lopez, MD         
Contact    (0)2086613539      
Principal Investigator: Juanita Lopez, MD         
Sponsors and Collaborators
Immunocore Ltd
Investigators
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Study Director: Shaad Abdullah, MD Immunocore Ltd

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Responsible Party: Immunocore Ltd
ClinicalTrials.gov Identifier: NCT03515551     History of Changes
Other Study ID Numbers: IMCnyeso-101
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Immunocore Ltd:
IMCnyeso
Immunotherapy