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

October 16, 2024 updated by: Immunocore Ltd

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 maximum tolerated dose (MTD) and/or expansion dose of IMC-C103C as a single agent administered intravenously (IV) and subcutaneously (SC) once weekly (Q1W) and administered Q1W in combination with once every 3 weeks (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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Barcelona, Spain, 8035
        • Hospital Universitario Vall d'Hebron
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz - PPDS
      • Madrid, Spain, 28027
        • Clinica Universidad Navarra
      • Pamplona, Spain, 31008
        • Clinica Universidad Navarra
  • United Kingdom
      • Bebington, United Kingdom, CH634JY
        • The Clatterbridge Hospital Cancer Center
      • London, United Kingdom, W1G 6AD
        • Sarah Cannon Research Institute
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 OYN
        • Beatson West of Scotland Cancer Centre
  • United States
    • California
      • Los Angeles, California, United States, 90025
        • The Angeles Clinic and Research Institute
      • Sacramento, California, United States, 95817
        • University of California Davis Comprehenvise Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medicine & Biological Sciences
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Medical center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute at Tennessee Oncology
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. HLA-A*02:01 positive
  2. MAGE-A4 positive tumor
  3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) [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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IMC-C103C and atezolizumab dose escalation
n=approximately 12 patients to establish the MTD/expansion dose
Drug: IMC-C103C
Weekly IV infusions
Other Names:
  • TECENTRIQ
  • Atezolizumab
  • Q3W
Drug: IMC-C103C
Weekly subcutaneous Injection
Drug: Atezolizumab
IV infusions every 3 weeks
Other Names:
  • 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
Other Names:
  • TECENTRIQ
  • Atezolizumab
  • Q3W
Drug: IMC-C103C
Weekly subcutaneous Injection
Experimental: IMC-C103C monotherapy SC dose escalation
Patients will be enrolled n=9-12 to establish the MTD/expansion dose
Drug: IMC-C103C
Weekly IV infusions
Other Names:
  • TECENTRIQ
  • Atezolizumab
  • Q3W
Drug: IMC-C103C
Weekly subcutaneous Injection
Experimental: IMC-C103C - Monotherapy IV dose escalation
n= approximately 50 patients to establish the MTD/expansion dose
Drug: IMC-C103C
Weekly IV infusions
Other Names:
  • TECENTRIQ
  • Atezolizumab
  • Q3W
Drug: IMC-C103C
Weekly subcutaneous Injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phase 2: Best overall response (BOR)
Time Frame: from first dose to approximately 2 years
from first dose to approximately 2 years
Phase 1: Incidence of dose-limiting toxicities (DLT)
Time Frame: From first dose to DLT period (28 days)
From first dose to DLT period (28 days)
Phase 1: incidence and severity of adverse events (AE)
Time Frame: from first dose to 30 days after the last dose
from first dose to 30 days after the last dose
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
from first dose to 30 days after the last dose
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
from first dose to 30 days after the last dose
Phase 1: dose interruptions, reductions, and discontinuations
Time Frame: from first dose through last dose (anticipated for up to 12-24 months)
from first dose through last dose (anticipated for up to 12-24 months)
Phase 1: changes in electrocardiogram parameters
Time Frame: from first dose to 30 days after the last dose
QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval absolute values and changes from baseline will be summarized
from first dose to 30 days after the last dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: from first dose to approximately 2 years
from first dose to approximately 2 years
Phase 2: incidence and severity of adverse events (AE)
Time Frame: from first dose to 30 days after the last dose
from first dose to 30 days after the last dose
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
from first dose to 30 days after the last dose
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
from first dose to 30 days after the last dose
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
from first dose to 30 days after the last dose
Phase 2: dose interruptions, reductions, and discontinuations
Time Frame: from first dose through last dose (anticipated for up to 12-24 months)
from first dose through last dose (anticipated for up to 12-24 months)
Phase 1: Best overall response
Time Frame: from first dose to approximately 2 years
from first dose to approximately 2 years
Progression-free survival
Time Frame: from first dose to approximately 2 years
from first dose to approximately 2 years
Duration of response
Time Frame: from first dose to approximately 2 years
from first dose to approximately 2 years
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)
from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks)
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)
from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks)
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)
from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks)
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)
from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks)
Immunogenicity the incidence of anti-drug antibody formation
Time Frame: from first dose to 14 days after the last dose
from first dose to 14 days after the last dose
Changes in lymphocyte counts over time
Time Frame: from first dose to approx 4 weeks
from first dose to approx 4 weeks
Changes in serum cytokines over time
Time Frame: from first dose to approx.. 4wks
from first dose to approx.. 4wks
GCIG CA-125 response (ovarian carcinoma)
Time Frame: from first dose to approx.. 30 days after the last dose
from first dose to approx.. 30 days after the last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Immunocore Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mohammed Dar, MD, Immunocore Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 25, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IMC-C103C-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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