Spots Global Cancer Trial Database for Study of FOLFIRI Plus Cetuximab Plus IMO-2055 in Patients With Colorectal Cancer

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Trial Identification

Brief Title: Study of FOLFIRI Plus Cetuximab Plus IMO-2055 in Patients With Colorectal Cancer

Official Title: Open-label Phase 1b Study of FOLFIRI Plus Cetuximab Plus IMO-2055 in Patients With Colorectal Cancer Who Have Progressed Following Chemotherapy for Advanced or Metastatic Disease

Study ID: NCT00719199

Conditions

Colorectal Cancer

Interventions

IMO-2055

Cetuximab

FOLFIRI

Study Description

Brief Summary: Open-label phase 1b trial. Study treatment will be administered in 3 week cycles. There are two distinct parts in this study: * Part 1: Dose escalation from IMO-2055 * Part 2: Once a recommended phase 2 dose is found additional tolerability and pharmacodynamics will be explored

Detailed Description: * Part 1: Dose escalation of IMO-2055, including 3 dose groups. Once a recommended phase 2 dosage (RP2D) of IMO-2055 given concomitantly with FOLFIRI and cetuximab is found the selected cohort will be expanded by an additional 6 to 9 patients (to a total of 12 patients) for confirmation of the RP2D and combination treatment regimen. * Part 2: A final cohort of 12 patients (Cohort 6) will be enrolled simultaneously to explore tolerability and pharmacodynamics in patients treated with the RP2D of IMO-2055 in combination with FOLFIRI with cetuximab.