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IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME
- Select Advanced Solid Tumors
- IMC-F106C
- IMC-F106C and atezolizumab and pembrolizumab
- IMC-F106C and chemotherapy
- IMC-F106C and tebentafusp
Phase 1/Phase 2
Interventional
Primary Outcome:
- Phase 1: Incidence of Dose-limiting toxicity (DLT)s
- Phase 1: incidence and severity of adverse events (AE) and serious adverse events (SAE)
- Phase 1: changes in laboratory parameters
- Phase 1: changes in vital signs
- Phase 1: changes in electrocardiogram parameters
- Phase 1: dose interruptions, reductions, and discontinuations
- Phase 2: Best overall response (BOR)
Secondary Outcome:
- Phase I: Best Overall Response (BOR)
- Progression-free survival (PFS)
- Duration of response (DOR)
- Overall survival
- Pharmacokinetics Area under the plasma concentration-time curve (AUC)
- Pharmacokinetics The maximum observed plasma drug concentration (Cmax)
- Pharmacokinetics The time to reach maximum plasma concentration (Tmax)
- Pharmacokinetics The elimination half-life (t1/2)
- Incidence of anti-IMC-F106C antibody formation
- Changes in lymphocyte counts over time
- Changes in serum cytokines over time
170
February 25, 2020
- Gender: All
- Minimum age: 18 Years
- Maximum age: N/A
- Healthy volunteers: No
Immunocore Ltd
Immunocore Ltd
Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers
NCT04262466
Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.