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Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab

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ClinicalTrials.gov Identifier: NCT03973333
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Immunocore Ltd

Brief Summary:
IMC-C103C is an immune mobilizing T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen MAGE-A4. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-C103C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for MAGE-A4.

Condition or disease Intervention/treatment Phase
Select Advanced Solid Tumors Drug: IMC-C103C Drug: Atezolizumab Phase 1 Phase 2

Detailed Description:

The IMC-C103C-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. To identify the MTD and/or RP2D of IMC-C103C as a single agent administered Q1W (Arm A1) and administered Q1W in combination with Q3W atezolizumab (Arm A2).
  2. To assess the preliminary anti-tumor activity of IMC C103C in one or more selected indications, as a single agent administered Q1W (Arm B1) and administered Q1W in combination with Q3W atezolizumab (Arm B2).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential from arm A1 to A2: B1 can be opened after A1, which will run parallel with A2 and B2 can be opened after A2
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 First-in-human Study of the Safety and Efficacy of IMC-C103C as Single Agent and in Combination With Atezolizumab in HLA-A*0201-positive Patients With Advanced MAGE-A4-positive Cancer
Actual Study Start Date : May 17, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IMC-C103C - Arm A1
n= approximately 28 patients to establish the MTD/RP2D
Drug: IMC-C103C
Weekly IV infusions

Experimental: IMC-C103C and atezolizumab Arm A2
n=approximately 12 patients to establish the MTD/RP2D
Drug: IMC-C103C
Weekly IV infusions

Drug: Atezolizumab
Q3W
Other Name: TECENTRIQ

Experimental: IMC-C103C - Arm B1
Patients will be enrolled n=9-24 metastatic/unresectable tumors of interest patients treated at the RP2D of IMC-C103C to assess preliminary anti-tumor efficacy
Drug: IMC-C103C
Weekly IV infusions

Experimental: IMC-C103C and atezolizumab Arm B2
Patients will be enrolled n=9-24 metastatic/unresectable tumors of interest patients treated at the RP2D of IMC-C103C to assess preliminary anti-tumor efficacy
Drug: IMC-C103C
Weekly IV infusions

Drug: Atezolizumab
Q3W
Other Name: TECENTRIQ




Primary Outcome Measures :
  1. Phase 1: Incidence of dose-limiting toxicities (DLT) [ Time Frame: From first dose to DLT period (21 days) ]
  2. Phase 1: incidence and severity of adverse events (AE) [ 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 ]
    Abnormalities will be classified according to NCI CTCAE v5.0

  4. Phase 1: changes in vital signs [ Time Frame: from first dose to 30 days after the last dose ]
    Abnormalities will be classified according to NCI CTCAE v5.0

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

Secondary Outcome Measures :
  1. Phase 2: incidence and severity of adverse events (AE) [ Time Frame: from first dose to 30 days after the last dose ]
  2. Phase 2: changes in laboratory parameters [ Time Frame: from first dose to 30 days after the last dose ]
    Abnormalities will be classified according to NCI CTCAE v5.0

  3. Phase 2: changes in vital signs [ Time Frame: from first dose to 30 days after the last dose ]
    Abnormalities will be classified according to NCI CTCAE v5.0

  4. Phase 2: 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

  5. Phase 2: dose interruptions, reductions, and discontinuations [ Time Frame: from first dose through last dose (anticipated for up to 12 months) ]
  6. Phase 1: Best overall response [ Time Frame: from first dose to approximately 2 years ]
  7. Progression-free survival [ Time Frame: from first dose to approximately 2 years ]
  8. Duration of response [ Time Frame: from first dose to approximately 2 years ]
  9. Overall survival [ Time Frame: from first dose to approximately 2 years ]
  10. Pharmacokinetics Area under the plasma concentration-time curve (AUC) [ Time Frame: 2 weeks (IMC-C103C AUC will be assessed weekly for 2 weeks) ]
  11. Pharmacokinetics The maximum observed plasma drug concentration after single dose administration (Cmax) [ Time Frame: 2 weeks (IMC-C103C AUC will be assessed weekly for 2 weeks) ]
  12. Pharmacokinetics The time to reach maximum plasma concentration (Tmax) [ Time Frame: 2 weeks (IMC-C103C AUC will be assessed weekly for 2 weeks) ]
  13. Pharmacokinetics The elimination half-life (t1/2) [ Time Frame: 2 weeks (IMC-C103C AUC will be assessed weekly for 2 weeks) ]
  14. Immunogenicity the incidence of anti-drug antibody formation [ Time Frame: 4 weeks ]
  15. Changes in lymphocyte counts over time [ Time Frame: 4 weeks ]
  16. Changes in serum cytokines over time [ Time Frame: 4 weeks ]
    Cytokine / chemokine concentration data will be listed, summarized, or analyzed by treatment group for Phase 1 and separately for each Phase 2 cohort.



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. HLA-A*02:01 positive
  2. MAGE-A4 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): NCT03973333


Contacts
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Contact: Mohammed Dar, MD 484-534-5261 clinicaltrials@immunocore.com

Locations
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United States, California
The Angeles Clinic and Research Institute Recruiting
Los Angeles, California, United States, 90025
Contact: Rodolfo Gutierrez, MD    310-231-2176      
Principal Investigator: Rodolfo Gutierrez, MD         
United States, Pennsylvania
UPMC Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Diwakar Davar, MD    412-623-5950      
Contact: Diwakar Davar, MD         
United States, Tennessee
Sarah Cannon Research Institute at Tennesse Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: Melissa Johnson, MD    615-986-4366      
Principal Investigator: Melissa Johnson, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: George Blumenschein, MD    713-792-6363      
Principal Investigator: George Blumenschein, MD         
Sponsors and Collaborators
Immunocore Ltd
Investigators
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Study Director: Mohammed Dar, MD Immunocore Ltd

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Responsible Party: Immunocore Ltd
ClinicalTrials.gov Identifier: NCT03973333     History of Changes
Other Study ID Numbers: IMC-C103C-101
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs