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

Conditions

1. Select Advanced Solid Tumors

Interventions

1. Drug: IMC-F106C
2. 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 ---