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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03515551
Recruitment Status : Terminated (Strategic decision to stop development and not based on any safety concerns)
First Posted : May 3, 2018
Results First Posted : March 11, 2022
Last Update Posted : March 11, 2022
Sponsor:
Information provided by (Responsible Party):
Immunocore Ltd

Study Description
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Brief Summary:
IMCnyeso is a bispecific fusion protein designed for the treatment of cancers that express NY-ESO-1 and/or LAGE-1A. This was a first-in-human trial designed to evaluate the safety and efficacy of IMCnyeso in HLA-A*02:01-positive adult participants 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 was planned to be a multi-center, open label, dose finding Phase 1/2 study of single agent IMCnyeso administered in participants with NY-ESO-1 and/or LAGE-A1 positive tumors. The primary objective of the dose escalation phase (Phase 1) was to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of IMCnyeso in participants with advanced solid tumors. Preliminary efficacy was to be evaluated in Phase 2. The study was terminated early (prior to initiation of Phase 2) by the Sponsor as a strategic decision (not based on any safety signal).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 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
Actual Primary Completion Date : May 10, 2021
Actual Study Completion Date : May 10, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1: Dose Escalation
Four fixed-dose, dose escalation cohorts (Cohorts 1 to 4) and 3 intrapatient dose escalation cohorts (Cohorts 5 to 7) to establish the MTD/RP2D of IMCnyeso.
 Drug: IMCnyeso
Weekly IV infusions of IMCnyeso
Experimental: Phase 2: Dose Expansion
Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. Phase 2 was not initiated and data were not collected.
 Drug: IMCnyeso
Weekly IV infusions of IMCnyeso


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1: Number of Participants With Dose-limiting Toxicities [ Time Frame: Up to 35 months ]
    Dose-limiting toxicities were defined as an adverse event or abnormal laboratory value assessed as having a suspected relationship to study drug that occurs within the evaluation period, from the first dose up until Day 28 after the first dose

  2. Phase 1: Number of Participants With Adverse Events [ Time Frame: Up to 35 months ]
    Treatment-emergent adverse events are defined as any adverse event (AE) that started after the first dose of study drug up to 30 days after last dose of study drug, including abnormal laboratory values, vital signs, or electrocardiogram results. AE severity is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.

  3. Phase 1: Number of Participants With No Dose Interruptions or Reductions [ Time Frame: Up to 35 months ]
    Tolerability of study treatment was assessed by summarizing the number of participants with no treatment dose interruptions and dose reductions

  4. Phase 2: Best Overall Response (BOR) [ Time Frame: Up to 35 months ]
    Best overall response per RECIST v.1.1


Secondary Outcome Measures :
  1. Phase 2: Number of Participants With Adverse Events [ Time Frame: Up to 35 months ]
    Treatment-emergent adverse events are defined as any adverse event (AE) that started after the first dose of study drug up to 30 days after last dose of study drug, including abnormal laboratory values, vital signs, or electrocardiogram results.

  2. Phase 2: Number of Participants With No Dose Interruptions or Reductions [ Time Frame: Up to 35 months ]
    Tolerability of study treatment was assessed by summarizing the number of participants with no treatment dose interruptions and dose reductions

  3. Phase 1: Number of Participants With Best Overall Response (BOR) [ Time Frame: Up to 35 months ]
    Number of participants with best overall response, including complete response, partial response, stable disease, and progressive disease, based on local Investigator assessment as defined in RECIST v.1.1.

  4. Phase 1 and Phase 2: Progression-free Survival [ Time Frame: Up to 35 months ]
    Progression-free survival is defined as the time from first dose until the date of objective progression, or death from any cause, whichever occurs first.

  5. Phase 1 and Phase 2: Duration of Response [ Time Frame: Up to 35 months ]
    Duration of response is defined as the time from the date of first documented objective response (CR or PR) until the date of documented disease progression or death.

  6. Phase 1 and Phase 2: Overall Survival [ Time Frame: Up to 35 months ]
    Overall Survival is defined as the time (in months) from the date of randomization to the date of death due to any cause.

  7. Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) [ Time Frame: Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15 ]
  8. Maximum Observed Plasma Drug Concentration After Single Dose Administration (Cmax) [ Time Frame: Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15 ]
  9. Time to Reach Maximum Plasma Concentration (Tmax) [ Time Frame: Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15 ]
  10. Number of Participants With Anti-IMCnyeso Antibody Formation [ Time Frame: Up to 35 months ]
    Number of participants with positive treatment-boosted or treatment-induced anti-IMCnyeso antibody titers


Eligibility Criteria
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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. 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
Contacts and Locations
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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


Locations
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United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
United States, Iowa
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
United States, Missouri
Washington University School of Medicine in St. Louis
Saint Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
UPMC - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Tennessee Oncology NASH - SCRI
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
United Kingdom
Sarah Cannon Research Institute UK
London, United Kingdom, W1G 6AD
The Christie Hospital
Manchester, United Kingdom, M20 4BX
Royal Marsden Hospital
Sutton, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Immunocore Ltd
Investigators
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Study Director: Study Director Immunocore Ltd
  Study Documents (Full-Text)

Documents provided by Immunocore Ltd:
Study Protocol  [PDF] February 24, 2020
Statistical Analysis Plan  [PDF] February 8, 2021

More Information
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Responsible Party: Immunocore Ltd
ClinicalTrials.gov Identifier: NCT03515551    
Other Study ID Numbers: IMCnyeso-101
First Posted: May 3, 2018    Key Record Dates
Results First Posted: March 11, 2022
Last Update Posted: March 11, 2022
Last Verified: March 2022
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