Colorectal Cancer Clinical Trial
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
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
- 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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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