A Phase 1/2 interventional study of IMC-C103C and Atezolizumab in Select Advanced Solid Tumors, sponsored by Immunocore Ltd. Withdrawn at 19 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-18.
Sponsored by Immunocore Ltd · Phase 1/2, Interventional, and Treatment
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.
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.
Immunocore Ltd is the lead sponsor of 14 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
n= approximately 50 patients to establish the MTD/expansion dose
Drug: IMC-C103C
n=approximately 12 patients to establish the MTD/expansion dose
Drug: IMC-C103C · Drug: Atezolizumab
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
Patients will be enrolled n=9-12 to establish the MTD/expansion dose
Drug: IMC-C103C
Weekly IV infusions
IV infusions every 3 weeks
Also known as: TECENTRIQ
Weekly subcutaneous Injection
Phase 1: Incidence of dose-limiting toxicities (DLT)
Time frame: 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
Phase 1: changes in laboratory parameters
Abnormalities will be classified according to NCI CTCAE v5.0
Time frame: from first dose to 30 days after the last dose
Phase 1: changes in vital signs
Abnormalities will be classified according to NCI CTCAE v5.0
Time frame: from first dose to 30 days after the last dose
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
Time frame: 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)
Phase 2: Best overall response (BOR)
Time frame: 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
Phase 2: changes in laboratory parameters
Abnormalities will be classified according to NCI CTCAE v5.0
Time frame: from first dose to 30 days after the last dose
Phase 2: changes in vital signs
Abnormalities will be classified according to NCI CTCAE v5.0
Time frame: from first dose to 30 days after the last dose
Phase 2: changes in electrocardiogram parameters
QTcF interval absolute values and changes from baseline will be summarized
Time frame: 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)
Phase 1: Best overall response
Time frame: from first dose to approximately 2 years
Progression-free survival
Time frame: from first dose to approximately 2 years
Duration of response
Time frame: from first dose to approximately 2 years
Overall survival
Time frame: 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)
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)
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)
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)
Immunogenicity the incidence of anti-drug antibody formation
Time frame: 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
Changes in serum cytokines over time
Time frame: 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
This study is withdrawn, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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