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

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: NCT03973333
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : March 7, 2023
Sponsor:
Information provided by (Responsible Party):
Immunocore Ltd

Study Description
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Brief Summary:
IMC-C103C is an immune mobilizing monoclonal 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 expansion dose of IMC-C103C as a single agent administered IV and SC Q1W and administered Q1W in combination with Q3W atezolizumab.
  2. To assess the preliminary anti-tumor activity of IMC-C103C in one or more selected indications, as a single agent administered Q1W.
Study Design
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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 monotherapy IV dose escalation is opened first; then monotherapy SC dose escalation, monotherapy expansion and combination dose escalation may run
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 : July 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: IMC-C103C - Monotherapy IV dose escalation
n= approximately 50 patients to establish the MTD/expansion dose
 Drug: IMC-C103C
Weekly IV infusions
Experimental: IMC-C103C and atezolizumab dose escalation
n=approximately 12 patients to establish the MTD/expansion dose
 Drug: IMC-C103C
Weekly IV infusions

Drug: Atezolizumab
IV infusions every 3 weeks
Other Name: TECENTRIQ
Experimental: IMC-C103C - expansion
Patients will be enrolled n=9-24 per expansion cohort (up to 4 total): metastatic/unresectable tumors of interest patients treated at the expansion dose of IMC-C103C to assess preliminary anti-tumor efficacy
 Drug: IMC-C103C
Weekly IV infusions
Experimental: IMC-C103C monotherapy SC dose escalation
Patients will be enrolled n=9-12 to establish the MTD/expansion dose
 Drug: IMC-C103C
Weekly subcutaneous Injection


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1: Incidence of dose-limiting toxicities (DLT) [ Time Frame: From first dose to DLT period (28 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 12-24 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 12-24 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: from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks) ]
  11. Pharmacokinetics The maximum observed plasma drug concentration after single dose administration (Cmax) [ Time Frame: from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks) ]
  12. Pharmacokinetics The time to reach maximum plasma concentration (Tmax) [ Time Frame: from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks) ]
  13. Pharmacokinetics The elimination half-life (t1/2) [ Time Frame: from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks) ]
  14. Immunogenicity the incidence of anti-drug antibody formation [ Time Frame: from first dose to 14 days after the last dose ]
  15. Changes in lymphocyte counts over time [ Time Frame: from first dose to approx 4 weeks ]
  16. Changes in serum cytokines over time [ Time Frame: from first dose to approx.. 4wks ]
  17. GCIG CA-125 response (ovarian carcinoma) [ Time Frame: from first dose to approx.. 30 days after the last dose ]

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*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 (expansion)
  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
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): NCT03973333


Contacts
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Contact: Mohammed Dar, MD 844-466-8661 clinicaltrials@immunocore.com

Locations
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Sponsors and Collaborators
Immunocore Ltd
Investigators
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Study Director: Mohammed Dar, MD Immunocore Ltd
More Information
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Responsible Party: Immunocore Ltd
ClinicalTrials.gov Identifier: NCT03973333    
Other Study ID Numbers: IMC-C103C-101
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: March 2023

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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:
ImmTAC, IMC-C103C, MAGE-A4, immunotherapy
Additional relevant MeSH terms:
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Atezolizumab
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents