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Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors

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: NCT04262466
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
Immunocore Ltd

Brief Summary:
IMC-F106C is an immune-mobilizing T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME

Condition or disease Intervention/treatment Phase
Select Advanced Solid Tumors Drug: IMC-F106C Drug: anti-PD(L)1 Phase 1 Phase 2

Detailed Description:

The IMC-F106C-101 Phase 1/2 study will be evaluated in patients with metastatic/unresectable tumors which include select Advanced Solid Tumors and will be conducted in two phases.

  1. Phase 1: To identify the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 dose (RP2D) of IMC-F106C as a single agent (Arm A) and administered in combination with Checkpoint Inhibitors (Arm B).
  2. Phase 2: To assess the preliminary anti-tumor activity of IMC-F106C in up to 4 indications, as a single agent administration.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential Assignment from Arm A to B: B can be opened after at least 3 cohorts have been enrolled in Arm A
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers
Actual Study Start Date : February 25, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2024

Arm Intervention/treatment
Experimental: IMC-F106C - Arm A - Phase 1
Dose Escalation
Drug: IMC-F106C
Weekly IV Infusions

Experimental: IMC-F106C and an anti-PD(L)1 agent - Arm B - Phase 1
Dose Escalation
Drug: IMC-F106C
Weekly IV Infusions

Drug: anti-PD(L)1
Every 3 weeks

Experimental: IMC-F106C - Phase 2
Monotherapy dose expansion
Drug: IMC-F106C
Weekly IV Infusions




Primary Outcome Measures :
  1. Phase 1: Incidence of Dose-limiting toxicity (DLT)s [ Time Frame: From first dose to DLT period (28 days) ]
  2. Phase 1: incidence and severity of adverse events (AE) and serious adverse events (SAE) [ Time Frame: from first dose to 30 days after the last dose ]
  3. Phase 1: changes in laboratory parameters [ Time Frame: from first dose to 30 days after the last dose ]
    Number of participants with, and rate of, Grade 1, Grade 2, Grade 3, and Grade 4 (as applicable per NCI CTCAE v5.0) laboratory abnormalities

  4. Phase 1: changes in vital signs [ Time Frame: from first dose to 30 days after the last dose ]
    Number of participants with, and rate of, Grade 1, Grade 2, Grade 3, and Grade 4 (as applicable per NCI CTCAE v5.0) vital sign abnormalities

  5. Phase 1: changes in electrocardiogram parameters [ Time Frame: from first dose to 30 days after the last dose ]
    QTcF interval absolute values and changes from baseline will be summarized

  6. Phase 1: dose interruptions, reductions, and discontinuations [ Time Frame: from first dose through last dose (anticipated for up to 12 months) ]
    Number of participants with, and rate of, dose interruption, dose reduction, permanent discontinuation of study treatment Number of participants with, and rate of, dose interruption, dose reduction, permanent discontinuation of study treatment due to adverse event Number of participants with, and rate of, dose interruption, dose reduction, permanent discontinuation of study treatment due to treatment-related adverse event

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

Secondary Outcome Measures :
  1. Phase I: Best Overall Response (BOR) [ Time Frame: from first dose to approximately 2 years ]
  2. Progression-free survival (PFS) [ Time Frame: from first dose to approximately 2 years ]
  3. Duration of response (DOR) [ Time Frame: from first dose to approximately 2 years ]
  4. Overall survival [ Time Frame: from first dose to approximately 2 years ]
  5. Pharmacokinetics Area under the plasma concentration-time curve (AUC) [ Time Frame: approximately 3 weeks (IMC-F106C AUC will be assessed for ~3 weeks) ]
  6. Pharmacokinetics The maximum observed plasma drug concentration (Cmax) [ Time Frame: approximately 3 weeks (IMC-F106C Cmax will be assessed for ~3 weeks) ]
  7. Pharmacokinetics The time to reach maximum plasma concentration (Tmax) [ Time Frame: approximately 3 weeks (IMC-F106C Tmax will be assessed for ~3 weeks) ]
  8. Pharmacokinetics The elimination half-life (t1/2) [ Time Frame: approximately 3 weeks (IMC-F106C t1/2 will be assessed for ~ 3 weeks) ]
  9. Incidence of anti-IMC-F106C antibody formation [ Time Frame: approximately 2 years ]
  10. Changes in lymphocyte counts over time [ Time Frame: approximately 3 weeks ]
  11. Changes in serum cytokines over time [ Time Frame: approximately 3 weeks ]


Information from the National Library of Medicine

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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. ECOG PS 0 or 1
  2. HLA-A*02:01 positive
  3. PRAME positive tumor
  4. Relapsed from, refractory to, or intolerant of standard therapy
  5. If applicable, must agree to use highly effective contraception
  6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol

Exclusion Criteria:

  1. Symptomatic or untreated central nervous system metastasis
  2. Recent bowel obstruction
  3. Ascites requiring recurrent paracentesis
  4. Significant immune-mediated adverse event with prior immunotherapy (patients in combination treatment)
  5. Inadequate washout from prior anticancer therapy
  6. Significant ongoing toxicity from prior anticancer treatment
  7. Out-of-range laboratory values
  8. Clinically significant medical condition
  9. Ongoing requirement for immunosuppressive treatment
  10. Prior solid organ or bone marrow transplant
  11. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  12. Known history of human immunodeficiency virus (HIV)
  13. Significant secondary malignancy
  14. Hypersensitivity to study drug or excipients
  15. Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study intervention
  16. Pregnant or lactating

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): NCT04262466


Contacts
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Contact: Shaad Abdullah, MD, FACP 484-534-5261 clinicaltrials@immunocore.com

Locations
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United States, California
Angeles Clinic and Research Institute Recruiting
Los Angeles, California, United States, 90025
Contact: Roland Menendez       rmenendez@theangelesclinic.org   
Principal Investigator: Omid Hamid, MD         
University of California Davis Comprehenvise Center Recruiting
Sacramento, California, United States, 95817
Contact: Steffany Lim       sllim@ucdavis.edu   
Contact: Frances Lara       fnlara@ucdavis.edu   
Principal Investigator: May Cho, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Suzanne Mistretta    212-304-6351    sm3435@cumc.columbia.edu   
Principal Investigator: Emerson Lim, MD         
United States, Oklahoma
University of Oklahoma Peggy and Charles Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Sarah Homan       sarah-homan@ouhsc.edu   
Contact: Kiersten During       kiersten-durning@ouhsc.edu   
Principal Investigator: Raid Aljumaly, MD         
University of Oklahoma Peggy and Charles Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Kiersten Durning       kiersten-durning@ouhsc.edu   
Principal Investigator: Raid Aljumaily, MD         
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Joshua Zigmot       joshua.zigmont@jefferson.edu   
Contact: Kathrine Senter       Katherine.Senter@jefferson.edu   
Principal Investigator: Takami Sato, MD         
UPMC Hillman Cancer Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Amy Rose       kennaj@upmc.edu   
Contact: Krystle Eaton       mientkiewiczk@upmc.edu   
Principal Investigator: Diwakar Davar, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Whitney Burroughs       whitney.burroughs@sarahcannon.com   
Principal Investigator: Melissa Johnson, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jeane Painter       jmgovan@mdanderson.org   
Principal Investigator: Ectaerina Dumbrava, MD         
United Kingdom
Sarah Cannon Research Institute UK Not yet recruiting
London, City Of London, United Kingdom, W1G6AD
Contact: Maria Victoria Borja Beral       mariavictoria.borjabernal@hcahealthcare.co.uk   
Contact: Juan Pedro Navarro Garcia       juanpedro.navarrogarcia@hcahealthcare.co.uk   
Principal Investigator: Tobias Arkenau, MD         
University College Hospital London Not yet recruiting
London, United Kingdom, W1T7HA
Contact: Shazia Begum       shazia.begum4@nhs.net   
Principal Investigator: Heather Shaw, MD         
Royal Marsden Hospital Not yet recruiting
Surrey Quays, United Kingdom, SM25PT
Contact: Dan Bar       dan.bar@icr.ac.uk   
Contact: Mahesha Ganegoda       mahesha.ganegoda@icr.ac.uk   
Principal Investigator: Juanita Lopez, MD         
Sponsors and Collaborators
Immunocore Ltd
Investigators
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Study Director: Shaad Abdullah, MD, FACP Immunocore Ltd
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Responsible Party: Immunocore Ltd
ClinicalTrials.gov Identifier: NCT04262466    
Other Study ID Numbers: IMC-F106C-101
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No