SNPMiner Trials (Home Page)
Report for Mutation F106C
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers
IMC-F106C is an immune-mobilizing 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
NCT04262466 Select Advanced Solid Tumors Drug: IMC-F106C Drug: anti-PD(L)1
Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers. --- F106C ---
Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors IMC-F106C is an immune-mobilizing T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. --- F106C ---
Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors IMC-F106C is an immune-mobilizing T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. --- F106C --- --- F106C ---
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 Phase 1: Incidence of Dose-limiting toxicity (DLT)s. --- F106C ---
Incidence of anti-IMC-F106C antibody formation. --- F106C ---
Pregnant or lactating Select Advanced Solid Tumors The IMC-F106C-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. --- F106C ---
1. Phase 1: To identify the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 dose (RP2D) of IMC-F106C as a single agent (Arm A) and administered in combination with Checkpoint Inhibitors (Arm B). 2. Phase 2: To assess the preliminary anti-tumor activity of IMC-F106C in up to 4 indications, as a single agent administration. --- F106C ---
1. Phase 1: To identify the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 dose (RP2D) of IMC-F106C as a single agent (Arm A) and administered in combination with Checkpoint Inhibitors (Arm B). 2. Phase 2: To assess the preliminary anti-tumor activity of IMC-F106C in up to 4 indications, as a single agent administration. --- F106C --- --- F106C ---
Primary Outcomes
Measure: Phase 1: Incidence of Dose-limiting toxicity (DLT)s Time: From first dose to DLT period (28 days)Measure: Phase 1: incidence and severity of adverse events (AE) and serious adverse events (SAE) Time: from first dose to 30 days after the last dose
Description: Number of participants with, and rate of, Grade 1, Grade 2, Grade 3, and Grade 4 (as applicable per NCI CTCAE v5.0) laboratory abnormalities of anemia, activated partial thromboplastin time prolonged, alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hemoglobin increased, INR increased, lipase increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, serum amylase increased, white blood cell decreased, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, chronic kidney disease, proteinuria.
Measure: Phase 1: changes in laboratory parameters Time: from first dose to 30 days after the last doseDescription: Number of participants with, and rate of, Grade 1, Grade 2, Grade 3, and Grade 4 (as applicable per NCI CTCAE v5.0) vital sign abnormalities of fever, hypothermia, weight gain, weight loss, hypoxia, hypertension
Measure: Phase 1: changes in vital signs Time: from first dose to 30 days after the last doseDescription: QTcF interval absolute values and changes from baseline will be summarized
Measure: Phase 1: changes in electrocardiogram parameters Time: from first dose to 30 days after the last doseDescription: Number of participants with, and rate of, dose interruption, dose reduction, permanent discontinuation of study treatment Number of participants with, and rate of, dose interruption, dose reduction, permanent discontinuation of study treatment due to adverse event Number of participants with, and rate of, dose interruption, dose reduction, permanent discontinuation of study treatment due to treatment-related adverse event
Measure: Phase 1: dose interruptions, reductions, and discontinuations Time: from first dose through last dose (anticipated for up to 12 months)Measure: Phase 2: Best overall response (BOR) Time: from first dose to approximately 2 years
Secondary Outcomes
Measure: Phase I: Best Overall Response (BOR) Time: from first dose to approximately 2 yearsMeasure: Progression-free survival (PFS) Time: from first dose to approximately 2 years
Measure: Duration of response (DOR) Time: from first dose to approximately 2 years
Measure: Overall survival Time: from first dose to approximately 2 years
Measure: Pharmacokinetics Area under the plasma concentration-time curve (AUC) Time: approximately 3 weeks (IMC-F106C AUC will be assessed for ~3 weeks)
Measure: Pharmacokinetics The maximum observed plasma drug concentration (Cmax) Time: approximately 3 weeks (IMC-F106C Cmax will be assessed for ~3 weeks)
Measure: Pharmacokinetics The time to reach maximum plasma concentration (Tmax) Time: approximately 3 weeks (IMC-F106C Tmax will be assessed for ~3 weeks)
Measure: Pharmacokinetics The elimination half-life (t1/2) Time: approximately 3 weeks (IMC-F106C t1/2 will be assessed for ~ 3 weeks)
Measure: Incidence of anti-IMC-F106C antibody formation Time: approximately 2 years
Measure: Changes in lymphocyte counts over time Time: approximately 3 weeks
Measure: Changes in serum cytokines over time Time: approximately 3 weeks