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Select Advanced Solid TumorsPhase 1/2NCT03973333

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

A Phase 1/2 study testing IMC-C103C and Atezolizumab in people with Select Advanced Solid Tumors, run by Immunocore Ltd at 19 sites in 3 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Select Advanced Solid Tumors
What is being tested?
IMC-C103C and Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
19 sitesin 3 countries
Study dates
17 May 2019to 25 Sep 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HLA-A*02:01 positive
  • MAGE-A4 positive tumor
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) [ECOG PS] 0 or 1
  • Selected advanced solid tumors
  • Relapsed from, refractory to, or intolerant of standard therapy
  • Measurable disease per RECIST v1.1 (expansion)
  • If applicable, must agree to use highly effective contraception

Who cannot join

  • Symptomatic or untreated central nervous system metastasis
  • Inadequate washout from prior anticancer therapy
  • Significant ongoing toxicity from prior anticancer treatment
  • Impaired baseline organ function as evaluated by out-of-range laboratory values
  • Clinically significant cardiac disease
  • Active infection requiring systemic antibiotic therapy
Show all 11Show fewer
  • Known history of human immunodeficiency virus (HIV)
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Ongoing treatment with systemic steroids or other immunosuppressive therapies
  • Significant secondary malignancy
  • Pregnancy or lactation

Trial locations and contacts

19 sites in 3 countries.

19 sites in 3 countries

United States10 sites

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • The University of Chicago Medicine & Biological Sciences

    Chicago, Illinois, 60637

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • The Angeles Clinic and Research Institute

    Los Angeles, California, 90025

  • Sarah Cannon Research Institute at Tennessee Oncology

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • UPMC Cancer Center

    Pittsburgh, Pennsylvania, 15213

  • University of California Davis Comprehenvise Cancer Center

    Sacramento, California, 95817

Other trials in United States

United Kingdom5 sites

  • The Clatterbridge Hospital Cancer Center

    Bebington, CH634JY

  • Beatson West of Scotland Cancer Centre

    Glasgow, Scotland, G12 OYN

  • Sarah Cannon Research Institute

    London, W1G 6AD

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Royal Marsden Hospital

    Sutton, SM2 5PT

Other trials in United Kingdom

Spain4 sites

  • Hospital Universitario Vall d'Hebron

    Barcelona, 8035

  • Clinica Universidad Navarra

    Madrid, 28027

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046

  • Clinica Universidad Navarra

    Pamplona, 31008

Other trials in Spain

About this study

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

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.

Read the 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.
Being tested
IMC-C103C, Atezolizumab
Keywords
ImmTAC, IMC-C103C, MAGE-A4, immunotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMC-C103CDrug

    Weekly IV infusions

  • AtezolizumabDrug

    Also called TECENTRIQ

    IV infusions every 3 weeks

  • IMC-C103CDrug

    Weekly subcutaneous Injection

Study groups in NCT03973333
Study groupRoleWhat they receive
IMC-C103C - Monotherapy IV dose escalationExperimentaln= approximately 50 patients to establish the MTD/expansion dose
Receives: Drug: IMC-C103C
IMC-C103C and atezolizumab dose escalationExperimentaln=approximately 12 patients to establish the MTD/expansion dose
Receives: Drug: IMC-C103C; Drug: Atezolizumab
IMC-C103C - expansionExperimentalPatients 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
Receives: Drug: IMC-C103C
IMC-C103C monotherapy SC dose escalationExperimentalPatients will be enrolled n=9-12 to establish the MTD/expansion dose
Receives: Drug: IMC-C103C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Incidence of dose-limiting toxicities (DLT)

    Measured: From first dose to DLT period (28 days)

  2. Phase 1: incidence and severity of adverse events (AE)

    Measured: from first dose to 30 days after the last dose

  3. Phase 1: changes in laboratory parameters

    Abnormalities will be classified according to NCI CTCAE v5.0

    Measured: from first dose to 30 days after the last dose

  4. Phase 1: changes in vital signs

    Abnormalities will be classified according to NCI CTCAE v5.0

    Measured: from first dose to 30 days after the last dose

  5. Phase 1: changes in electrocardiogram parameters

    QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval absolute values and changes from baseline will be summarized

    Measured: from first dose to 30 days after the last dose

  6. Phase 1: dose interruptions, reductions, and discontinuations

    Measured: from first dose through last dose (anticipated for up to 12-24 months)

  7. Phase 2: Best overall response (BOR)

    Measured: from first dose to approximately 2 years

Secondary outcomes (17)

  1. Phase 2: incidence and severity of adverse events (AE)

    Measured: from first dose to 30 days after the last dose

  2. Phase 2: changes in laboratory parameters

    Abnormalities will be classified according to NCI CTCAE v5.0

    Measured: from first dose to 30 days after the last dose

  3. Phase 2: changes in vital signs

    Abnormalities will be classified according to NCI CTCAE v5.0

    Measured: from first dose to 30 days after the last dose

  4. Phase 2: changes in electrocardiogram parameters

    QTcF interval absolute values and changes from baseline will be summarized

    Measured: from first dose to 30 days after the last dose

  5. Phase 2: dose interruptions, reductions, and discontinuations

    Measured: from first dose through last dose (anticipated for up to 12-24 months)

  6. Phase 1: Best overall response

    Measured: from first dose to approximately 2 years

  7. Progression-free survival

    Measured: from first dose to approximately 2 years

  8. Duration of response

    Measured: from first dose to approximately 2 years

  9. Overall survival

    Measured: from first dose to approximately 2 years

  10. Pharmacokinetics Area under the plasma concentration-time curve (AUC)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: from first dose to 14 days after the last dose

  15. Changes in lymphocyte counts over time

    Measured: from first dose to approx 4 weeks

  16. Changes in serum cytokines over time

    Measured: from first dose to approx.. 4wks

  17. GCIG CA-125 response (ovarian carcinoma)

    Measured: from first dose to approx.. 30 days after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2019
  2. Study start17 May 2019 (estimated)
  3. Primary completion25 Sep 2023 (estimated)
  4. Study completion25 Sep 2023 (estimated)

Why it stopped: Study withdrawn by Sponsor

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
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)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03973333
Sponsor's protocol ID
IMC-C103C-101
Status last verified
Oct 2024
First submitted
23 May 2019
Last updated
18 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Sweis RF, Melero I, Davar D, Garralda E, Hamid O, Chen HA, Evans TRJ, Moore KN, Sacco JJ, Thistlethwaite F, Williams A, Blumenschein GR, Callahan MK, Johnson ML, Schenk EL, Wustner J, Stanhope S, Tao K, Marshall S, Lopez J. Phase 1/2 study of IMC-C103C, a T cell receptor bispecific (MAGE-A4xCD3) ImmTAC targeting MAGE-A4-expressing malignancies. J Immunother Cancer. 2026 Jul 20;14(7):e014638. doi: 10.1136/jitc-2025-014638.

    PubMed 42476725

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IMC-C103C and Atezolizumab in people with Select Advanced Solid Tumors, run by Immunocore Ltd at 19 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, United Kingdom, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Incidence of dose-limiting toxicities (DLT) (time frame: From first dose to DLT period (28 days)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03973333, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.

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